Patient‐Reported Outcome Measures (PROMs) and Clinician‐Reported Outcomes (ClinROs) in Sinus Floor Elevation for Implant Rehab in the Edentulous Maxilla: A Systematic Review and COSMIN Analysis

ABSTRACT

Objectives

To evaluate the current patient‐reported outcome measures (PROMs) and clinician‐reported outcomes (ClinROs) following sinus floor elevation (SFE) for implant‐based rehabilitation in the fully edentulous maxilla.

Methods

A systematic search was conducted across PubMed, EMBASE, Scopus, and the Cochrane Central Register of Controlled Trials, covering publications from 2013 to 2024. We included prospective studies assessing PROMs and ClinROs. The COSMIN checklist was used to evaluate PROMs quality.

Results

Eighteen studies met the inclusion criteria, comprising randomized controlled trials, controlled clinical trials, and case series. Fourteen distinct ClinROs were identified, predominantly implant survival (61.11%) and peri‐implant bone‐level changes (50%). Conversely, ClinROs directly associated with SFE procedures—such as maxillary sinus bone height/volume changes (27.7%) and sinus membrane perforation (10.5%)—were underreported. Prosthetic outcomes were addressed in 11.11% of studies, and PROMs in 50% of the studies. Seven different PROMs were identified, with a focus on masticatory function and overall satisfaction. COSMIN analysis revealed that OHIP‐49 and the denture satisfaction questionnaire (DSQ) were the most robust PROMs, scoring “very good” across multiple domains. Patients' overall satisfaction and complaint‐based PROMs lacked validation.

Conclusions

Current reporting of ClinROs emphasizes implant‐related metrics, while outcomes directly related to SFE are inconsistently reported. Validated PROMs are needed to ensure consistency and reliability in outcome assessment. OHIP‐49 and DSQ demonstrated strong psychometric properties and are recommended as core PROMs. Future studies should incorporate early and long‐term PROMs and adopt a standardized approach to outcome reporting.

1. Introduction

Dental implant procedures in the fully edentulous maxilla often necessitate complex surgical interventions, particularly when addressing bone deficiencies in the posterior region (Schwarz et al. 2021). Such deficiencies commonly arise from factors such as maxillary sinus pneumatization, vertical ridge deficiency, and advanced periodontal and peri‐apical pathology (Schwarz et al. 2021; Tran et al. 2021; Urban et al. 2021; Ramanauskaite et al. 2022). Additional procedures are frequently required to address these issues. Bone atrophy in this region often necessitates sinus floor elevation (SFE) to create a stable foundation for dental implants. Techniques such as lateral maxillary SFE and trans‐crestal SFE, short implants, and alternative approaches like pterygoid or zygomatic implants have been developed to address these challenges. These interventions aim to improve implant stability and success rates by augmenting the available bone volume (Lie et al. 2021; Rickert et al. 2014; Saleh et al. 2025).

The success criteria for implant therapy, which include factors like mobility, radiolucency, peri‐implant bone loss, suppuration, bleeding, and aesthetic outcomes, require comprehensive evaluation within the context of sinus augmentation (Thoma et al. 2023). Fundamentally, outcome assessments include survival measures, clinical outcome assessments (COAs), and biomarkers. COAs encompass any evaluation that may be influenced by human judgment, decision‐making, or motivation (Weinfurt 2025; Gilbert et al. 2016). They are classified into four categories: patient‐reported outcomes (PROs), clinician‐reported outcomes (ClinROs), observer‐reported outcomes (ObsROs), and performance outcomes (PerfOs) (Gilbert et al. 2016). In the context of modern implant therapy, the importance of ClinROs has increasingly been recognized. Traditionally, the success of dental implants was measured primarily through clinical parameters. However recent consensus reports highlight the necessity of incorporating patient‐reported outcome measures (PROMs) to assess patient satisfaction and quality of life, in all implant‐related clinical studies. The term PROMs, introduced in the eighth European workshop on periodontology (Berglundh et al. 2012), encompasses subjective reports of patient's perceptions of their oral health status, satisfaction with oral health status or care, and other non‐clinical assessments. This paradigm shift acknowledges the subjective experiences of patients, addressing their increasing aesthetic demands and concerns about pain and fear associated with oral surgical interventions (Stefanini et al. 2021; Hua 2022; Wadia 2023). A thorough evaluation of PROMs is crucial for a holistic understanding of outcomes and for optimizing patient‐centered care (Ravidà et al. 2019). Recently, there has been a growing interest in psychosocial parameters, which include patients' perceptions of implant treatment (Fonteyne et al. 2020). The final evaluation by patients, though subjective and challenging to quantify, is increasingly seen as pivotal (Hua 2022; Wadia 2023). Incorporating these psychosocial parameters into the assessment framework is vital for a comprehensive understanding of implant therapy outcomes. A systematic review by Mittal et al. (2019), identified 36 commonly used dental PROMs, including 20 distinct questionnaires. Notably, the “New Chewing Function Questionnaire,” “Oral Health Quality of Life,” and “Rand Dental Health Index” were among the most frequently reported measures.

The use of PROMs in conjunction with ClinROs offers a more comprehensive assessment of treatment outcomes. This dual approach helps in understanding the broader impact of implant therapies and identifying areas for improvement in patient care. Nonetheless, one of the significant concerns in oral health research is the lack of uniformity in selecting clinical outcomes for conditions like complete edentulism, partial edentulism, and bone atrophy. Often, direct clinical outcomes such as implant and prosthesis survival or patient health‐related variables are reported without standardized criteria or replaced by surrogate outcomes that lack validation, making them unreliable predictors (Faggion Jr. and Schmitter 2010). Additionally, there is a noticeable lack of standardization regarding which outcomes should be consistently reported and the methods used to measure them. This inconsistency leads to variability, subjectivity, and poor informative value across literature (Graziani et al. 2012; Meijer and Raghoebar 2012; Tonetti and Palmer 2012; Needleman et al. 2012). This systematic review aimed to comprehensively evaluate the current methods implemented to assess PROMs and ClinROs following SFE in the fully edentulous maxilla. Recognizing the importance of understanding variations in clinical use and potential gaps in evaluation, the study aims to provide insights into the tools employed for gauging the success of interventions in both clinical research and trial settings.

2. Materials and Methods

2.1. Study Design, Protocol, and Registration

This study was conceptualized within a systematic review and COnsensus‐based Standards for the selection of health Measurement INstruments (COSMIN) analysis design based on the latest standards and guidelines of this methodology (Prinsen et al. 2018; Mokkink et al. 2018) and reporting guidelines (Page et al. 2021). Registration of a priori protocol was carried out through the International Prospective Register of Systematic Reviews (PROSPERO) portal (CRD42024520303). The study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) statement (Page et al. 2021) (Table S1). Institutional Review Board (IRB) approval was deemed not required as this study exclusively utilized previously published data.

2.2. PICOST Elements and Focused Question

The following PICOST elements were defined to formulate the focused question.

(P) Population: Human adult (≥ 18 years) with a fully edentulous maxilla and a deficient bone height, necessitating additional pre‐implant interventions in order to achieve implant‐based rehabilitation.

(I) Intervention: SFE with or without simultaneous ridge augmentation, with various surgical techniques (lateral window or crestal) and grafting materials (no graft approach, autogenous grafts, allografts, xenografts, or their mixtures) with or without simultaneous implant placement for at least one site prior to dental implant rehabilitation.

(C) Comparison: Not applicable.

(O) Outcomes: The primary outcomes in this study were as follows: Methods/measures/techniques to assess PROs such as pain, discomfort, quality of life, overall satisfaction, and ClinROs such as surgical or post‐surgical complications, histomorphometry outcomes, vertical bone height, implant survival, and prevalence of peri‐implant diseases. In addition, the results of PROMs reported in the included studies were set as the secondary outcome of this systematic review.

(S) Study design: Any human prospective clinical studies with at least 10 patients per treatment arm (such as prospective randomized or non‐randomized controlled clinical trials [RCTs and CCTs] and prospective case series with a proper protocol [i.e., predefined inclusion/exclusion criteria, standardized treatment protocols, and structured follow‐up]).

(T) Timeframe: Articles published between 2013 and 2024 were considered. The decision to include studies published within the last 10 years was made by the organizing committee to ensure the inclusion of the most up‐to‐date and clinically relevant evidence, reflecting advancements in techniques, materials, and outcome measures in SFE for implant rehabilitation.

Based on the defined PICOST framework, the following focused question was considered:

In prospective clinical studies with at least 10 patients per treatment arm, published in the last 10 years on patients with an edentulous maxilla requiring SFE for implant placement, what are the common PROMs and ClinROs used to report the treatment outcomes?

2.3. Eligibility Criteria

2.3.1. Inclusion Criteria

• Prospective clinical studies with at least 10 patients per treatment arm.

• Fully edentulous maxilla.

• Sinus augmentation procedures with various grafting materials and techniques with or without simultaneous augmentation/implant placement.

• Studies reporting PROMs and/or ClinROs.

• Articles published in any language (no language limitations).

2.3.2. Exclusion Criteria

• Retrospective studies, case reports, any type of reviews, book chapters, commentaries, and technical notes as well as pre‐clinical studies (animal, in vitro, etc.)

• Studies with a patient cohort of fewer than 10 subjects.

• Studies lacking PROMs and/or ClinROs.

2.4. Search Strategy

A systematic search strategy was developed and carried out independently by two reviewers via PubMed (MEDLINE), EMBASE, Scopus, and the Cochrane Central Register of Controlled Trials up to April 10, 2024.

No restrictions were assigned regarding the journal or the language used. However, a 10‐year timeframe limitation was applied. Next, the search results (after duplicate removal and cross‐reference checks in additional reports and citation lists) were complemented with a manual hand search and screening of the following journals: Journal of Dental Research, Journal of Oral Rehabilitation, Journal of Clinical Periodontology, Journal of Periodontology, Clinical Oral Investigations, International Journal of Periodontics and Restorative Dentistry, Journal of Oral and Maxillofacial Surgery, International Journal of Oral and Maxillofacial Surgery, Journal of Prosthodontics, Journal of Prosthetic Dentistry, Clinical Oral Implants Research, Journal of Oral Implantology, International Journal of Oral Implantology, International Journal of Oral and Maxillofacial Implants, and Clinical Implant Dentistry and Related Research. The complete search strategy corresponding to each of the databases queried is presented in Table S2.

2.5. Study Selection Process

The output of all searched queries in the mentioned databases was entered into the Endnote software (version X9, Clarivate Analytics, Philadelphia, PA, USA). After duplicate removal, the titles and abstracts of all articles were screened by two independent authors (H.S., J.M.Z.). The full texts of potentially relevant studies were retrieved and reviewed based on eligibility criteria by the same independent reviewers. An inter‐examiner reliability test (using Cohen's Kappa test) was performed on the first 100 screened articles. An agreement of at least 85% was achieved between the two examiners before moving forward with the main title/abstract screening. Any disagreement at this stage was resolved with consultation with a senior author (M.H.A.S.).

2.6. Data Collection and Management

Studies that met the inclusion criteria underwent data collection by two independent reviewers (H.S., J.M.Z.). Data extraction was conducted in duplicate, and any discrepancies between the two reviewers were resolved through discussion. If disagreements persisted, a senior author (M.H.A.S.) was consulted for resolution. In addition to the bibliographic (authors, setting, study design, and funding, etc.) and intervention data (participants, treatment arms, SFE technique, and materials, etc.) information regarding the PROMs used as well as clinical outcomes (as ClinROs) were assessed. Any missing data that potentially could contribute to this systematic review was requested from the author(s) via email. In addition to qualitative assessment of the PROMs and ClinROs implemented in the studies, descriptive analysis of outcomes of PROMs and ClinROs in various groups and time points from the included studies was performed. Forest plots were generated for the corresponding outcomes to display mean or median scores along with standard deviations (SD) or interquartile ranges (IQR) [reported in Supporting Information]. All descriptive and statistical analyses were performed by one author (H.S.) and using Python software (version 3.11, Python Software Foundation, Wilmington, Delaware, USA), specifically, the “Matplotlib” (Tosi 2009) and “pandas” (McKinney and Team 2015) packages were used.

2.7. Quality Assessment and COSMIN Analysis

Measurement properties and the risk of bias in the development of included PROMs were assessed using COnsensus‐based Standards for the selection of health status Measurement INstruments (COSMIN) Taxonomy. COSMIN is an internationally recognized framework designed to evaluate the methodological quality of PROMs by systematically assessing their validity, reliability, and responsiveness. It provides structured criteria to ensure that PROMs are robust, standardized, and suitable for clinical and research applications. Measurement properties included content validity, structural validity, internal consistency, reliability, criterion validity, hypotheses testing for construct validity, and responsiveness, as defined by Mokkink et al. (2018). The quality of evidence for each property was summarized as sufficient, insufficient, or indeterminate using COSMIN criteria. Summary ratings for each property were determined using the lowest rating across property criteria (i.e., “worst score counts”), as specified by COSMIN guidelines; properties that were not reported were deemed inadequate, and the quality of the evidence was listed as “not applicable.” The data for each PROM was summarized independently. COSMIN assessments were conducted in duplicate by two independent reviewers (H.S., J.M.Z.), with discrepancies resolved through discussion and, when necessary, consultation with a senior author (M.H.A.S.).

To generate visualizations, each score is converted to a numeric scale from 1 (=Inadequate) to 5 (Very good). Figure 1 depicts the network plot of the performed COSMIN analysis and the implemented domains to assess the quality of PROMs. Also, Figure S1 summarizes the flowchart of the COSMIN methodology followed in this study.

FIGURE 1.

COSMIN framework and network plot. This network plot depicts the four main domains of the COSMIN tool as well as the sub‐categories of each domain.

3. Results

3.1. Study Selection

The initial search query resulted in 2897 articles, out of which 32 were selected to undergo full‐text assessment. Finally, 18 studies met the eligibility criteria. Inter‐examiner agreement using kappa score for title/abstract review and for full‐text review was 0.93 (95% CI: 0.86–1.0) and 0.89 (95% CI: 0.81–0.95), respectively. The reason for the exclusion of the articles that did not meet the eligibility criteria is presented in Table S3. Moreover, the PRISMA diagram of the study selection process is depicted in Figure 2.

FIGURE 2.

The PRISMA flowchart of the search strategy, article screening, and selection of this systematic review.

3.2. Characteristics of Included Studies

In total, 18 studies were included in this systematic review (Tran et al. 2021; Rickert et al. 2014; Macedo et al. 2021; Castagna et al. 2013; Putters et al. 2019; Boven et al. 2020, 2017; Wortmann et al. 2021; Mordenfeld et al. 2016; Urban et al. 2017; Xavier et al. 2015; Slot et al. 2019; Grandi et al. 2019; Lie et al. 2024; Hernández‐ Alfaro et al. 2013; Kappel et al. 2021; Onclin et al. 2023; Aly and Hammouda 2017). The time range of publication for the included studies spanned from 2013 to 2024. Out of these, 11 studies were (RCTs) (Tran et al. 2021; Rickert et al. 2014; Castagna et al. 2013; Boven et al. 2020; Wortmann et al. 2021; Xavier et al. 2015; Slot et al. 2019; Grandi et al. 2019; Lie et al. 2024; Kappel et al. 2021; Onclin et al. 2023), 2 were CCTs (Mordenfeld et al. 2016; Aly and Hammouda 2017), and 5 were case series (Macedo et al. 2021; Putters et al. 2019; Urban et al. 2017; Boven et al. 2017; Hernández‐ Alfaro et al. 2013). Bone augmentation, in addition to SFE, was performed in 7 studies (Macedo et al. 2021; Castagna et al. 2013; Putters et al. 2019; Wortmann et al. 2021; Urban et al. 2017; Boven et al. 2017; Hernández‐ Alfaro et al. 2013; Onclin et al. 2023). The majority of the studies (18) were conducted in university settings, except the study by Urban et al. (2017), which was conducted in private practice settings. Regarding funding, six studies (Rickert et al. 2014; Wortmann et al. 2021; Urban et al. 2017; Slot et al. 2019; Boven et al. 2017; Kappel et al. 2021) reported receiving funding, while the remaining twelve studies did not report any funding sources. In the included studies, various grafting materials were used for SFE. A total of twelve studies utilized autogenous grafts sourced from calvaria, iliac crest, retromolar pad, or ramus (Lie et al. 2021; Rickert et al. 2014; Macedo et al. 2021; Castagna et al. 2013; Putters et al. 2019; Boven et al. 2020; Wortmann et al. 2021; Urban et al. 2017; Xavier et al. 2015; Slot et al. 2019; Hernández‐ Alfaro et al. 2013; Aly and Hammouda 2017). Xenografts were used in 7 studies, primarily using bovine‐derived materials (Rickert et al. 2014; Boven et al. 2020, 2017; Mordenfeld et al. 2016; Urban et al. 2017; Grandi et al. 2019; Onclin et al. 2023). Allografts were employed in three studies, with materials including demineralized bone matrix (DBM) and fresh frozen femoral head (Xavier et al. 2015; Lie et al. 2024; Aly and Hammouda 2017). Alloplastic materials, specifically a commercially available biphasic calcium phosphate (BCP), were used in 1 study (Mordenfeld et al. 2016). Additionally, mixed materials combining autogenous grafts with xenografts were used in 4 studies (Lie et al. 2021; Rickert et al. 2014; Urban et al. 2017; Boven et al. 2017). Graftless techniques were reported in 2 studies, utilizing approaches such as resorbable membranes without additional grafting materials (Lie et al. 2021; Grandi et al. 2019). The summary of the bibliographic information, methodology, treatment arms, study conclusions, and implemented PROMs and ClinROs in the included studies is summarized in Table 1. Also, Figure 3 summarizes the time span of the included articles as well as the frequency of PROMs and ClinROs used in the included studies.

TABLE 1.

Summary of the included studies in this systematic review.

Author, year, country, study design, setting, funding	Study groups	N patients/implants/SFE site/implant plan/follow‐up time	Sinus floor elevation technique and materials	Simultaneous to bone augmentation? If yes, explain.	ClinROs	PROMs	Conclusions
Macedo et al. (2021), Brazil, Case series, University, NR	1. SFE + Implant placement	11/(NA)/21 SFEs/6 months	1. Lateral/autogenous (calvarial) particulate	1. Autogenous block graft (calvarial) for anterior maxilla	A. Difference in maxillary sinus height (anterior, medial, and posterior) B. Percentage of resorption in anterior, medial, and posterior sinus region	None	Significant increase in the height of the maxillary sinus floor after the use of particulate calvarial grafts
Castagna et al. (2013), Brazil, RCT, University, None	Bone augmentation and bilateral SFE followed by: 1. Immediate total prosthesis on temporary immediate implants (4 implants) 2. Complete denture after 60 days	1. 12/48/12/immediate total prosthesis on temporary immediate implants (4) 2. 4/NA/8/Complete denture after 60 days 6 months	1. Lateral/autogenous (iliac) particulate 2. Lateral/autogenous (iliac) particulate	1. Autogenous (iliac crest) block graft 2. Autogenous (iliac crest) block graft	A. Vertical bone gain, horizontal bone gain (CBCT) b. Infection requiring antibiotics and surgical re‐intervention	None	Treatment of atrophic maxillary reconstruction with iliac crest bone grafts and the use of immediate provisional implants is a good solution
Rickert et al. (2014), Netherlands, RCT, University, Funding for the enrichment procedures and histologic evaluation by Geistlich	Lateral SFE followed by: 1. Implant‐supported overdenture 2. Implant‐supported overdenture	1. 12/33/24/implant‐supported overdenture 2. 12/33/24/implant‐supported overdenture 12 months	1. Lateral/bio‐Oss + iliac crest bone marrow concentrate enriched in mesenchymal stem cells (MSCs) 2. Lateral/bio‐Oss + autogenous bone graft (retromolar mandible)	1. No 2. No	A. Plaque index B. Gingival index C. Bleeding index D. Probing depth, E. Peri‐implant marginal bone levels F. Implant Survival	A. Morbidity (Complications, postoperative morbidity, and patient acceptance of the procedure) B. Patient satisfaction questionnaire	The two techniques (BioOss + MSCs and BioOss + autogenous bone) for maxillary sinus floor elevation were shown to be equally reliable methods
Putters et al. (2019), Netherlands, Case Series, University, None	1. Implant‐supported overdenture	1. (13/68 both groups)/26/implant‐supported overdenture 4 months	Lateral/autogenous (calvarial) bone mass	1. Autogenous block graft (calvarial)	A. Perioperative complications (i.e., sinus membrane perforation) B. Primary stability C. Wound dehiscence D. Radiographic peri‐implant bone loss E. Bone biopsy (mineralized and newly deposited osteoid) F. Implant survival rate	A. Visual Analog Scale (VAS) for pain	Immediate placement of dental implants in calvarial bone grafts to rehabilitate a severely resorbed maxilla is technically feasible with high success rates
Aly and Hammouda (2017), Egypt, CCT, University, NR	Lateral SFE followed by: 1. Implant‐supported overdenture 2. Implant‐supported overdenture	1. 12/36/12/implant‐supported overdenture 2. 12/28/12/implant‐supported overdenture 18 months	1. Lateral/allograft demineralized bone matrix (DBM) putty form 2. Lateral/allograft (DBM) powder form	1. No 2. No	A. Implant success B. Marginal bone loss C. Implant stability quotient (ISQ)	VAS for postoperative pain	Both techniques for lateral approach to sinus elevation using piezo surgery technique was an effective means to achieve sinus elevation
Boven et al. (2020), Netherlands, RCT, University, None	1. Implant‐supported overdenture (locator attachments) 2. Implant‐supported overdenture (bar attachments)	1. 25/100/18/implant‐supported overdenture (locator) 2. 25/100/14/implant‐supported overdenture (bar) 12 months	1. Lateral/autogenous (tuberosity) + Xenograft (bovine) 2. Lateral/autogenous (tuberosity) + Xenograft (bovine)	1. No 2. No	A. Radiographic peri‐implant bone level B. Implant survival C. Overdenture survival D. Plaque index E. Gingiva index F. Sulcus bleeding index G. Probing depth	A. Denture satisfaction questionnaire B. Oral Health Impact Profile (OHIP‐49) C. Patient satisfaction questionnaire	Bone loss was within an acceptable range for both groups after 1 year
Lie et al. (2021), Netherlands, RCT, University, None	6‐implants fixed denture after: 1. Graftless SFE 2. Conventional SFE	1. 10/30/10/NA 2. 10/29/10/NA 6 months	1. Lateral/graftless SFE + resorbable membrane (poly(D,L)‐lactide) 2. Lateral SFE with mixture of autogenous bone harvested from the anterior iliac crest and DBBM (Bio‐Oss)	1. No 2. No	A. Radiographic bone gain (CBCT) B. Implant survival C. Implant success D. Prosthetic success	None	Non‐grafted techniques might have some potential for clinical use
Wortmann et al. (2021), Netherlands, RCT, University, Yes	Bilateral SFE and bone augmentation using: 1. Calvarial bone 2. Iliac crest	1. 10/(44)/20/NA 2. 10/(44)/20/NA 4/12 months	1. Lateral/autogenous (iliac crest) 2. Lateral/autogenous (calvarial)	1. Autogenous (iliac crest) block 2. Autogenous (calvarial) block	A. Implant survival rate (1 year) B. Microcomputed tomography analysis of tissue mineral density (TMD) C. Bone mineral density (BMD) and bone volume fraction (BVF) D. Histomorphometric analysis	None	Both donor sites, that is, anterior iliac crest and calvarial bone, are both well suited to provide a reliable and stable basis for implant placement
Mordenfeld et al. (2016), Sweden, CCT, University, NR	SFE with: 1. Bone ceramic and then fixed implant‐supported prosthesis 2. BioOss and then Fixed implant‐supported prosthesis	1. 11/62/22 (split‐mouth design) 5 years	1. Lateral SFE/Alloplast (Straumann Bone Ceramic, BCP) 2. Lateral SFE/Xenograft (Bio‐Oss)	1. No 2. No	A. Implant survival rate B. Implant success rate C. Marginal bone levels D. Grafted sinus height (panoramic Xray)	None	There was no statistically significant difference between SLActive implants placed after sinus augmentation with 100% Bio‐Oss or 100% Straumann Bone Ceramic
Urban et al. (2017), Hungary, Case Series, Private Practice, Yes	Bilateral SFE and bone augmentation followed by implant placement	16/(122)/32/NA/1–15 years	1. Lateral/autogenous (retromolar) + Xenograft (Bio‐Oss)	1. GBR with Autogenous (retromolar) + Xenograft (BioOss) and e‐pTFE titanium reinforced non‐resorbable membrane	A. Implant survival B. Peri‐impalnt bone level (radiographic) C. Bone Gain	None	Complete atrophied maxillary reconstruction can be successfully achieved by means of guided bone regeneration for horizontal and/or vertical bone gain including bilateral sinus augmentation
Xavier et al. (2015), Brazil, RCT, University, NR	Lateral SFE and implant placement, NA	1. 15/(40)/15/NA 2. 15/(40)/15/NA 6 months	1. Lateral/autogenous (ramus) 2. Lateral/allograft (fresh frozen femoral head [FFB])	1. No 2. No	1. Implant survival 2. Histology, and histomorphometry in % (connective tissue, new bone, and residual graft particles)	None	Use of FFB allografts for sinus floor augmentation can be supported
Slot et al. (2019), Netherlands, RCT, University, Yes	1. Implant‐supported overdenture (all on 4) 2. Implant‐supported overdenture (all on 6)	1. 33/(132)/66/implant‐supported overdenture (all on 4) 2. 33/(198)/66/implant‐supported overdenture (all on 6) 5 years	1. Lateral/autogenous (iliac crest) 2. Lateral/autogenous (iliac crest)	1. No 2. No	A. Peri‐implant bone height changes B. Implant and overdenture survival, C. Plaque index D. Presence of calculus E. Gingival index F. Sulcus bleeding index G. Pocket probing depth H. Changes in radiographic bone level	A. Denture satisfaction questionnaire B. Chewing ability questionnaire	Bar‐connected maxillary overdentures on either four or six implants that are placed in the posterior region of severely resorbed maxillas, lead to comparable treatment outcomes
Grandi et al. (2019), Italy, RCT, University, None	1. Trans‐sinus implants without bone grafting; All‐on 6, or all‐on 4 2. Trans‐sinus implants with bone grafting; All‐on 6, or all‐on 4	1. 16/(72)/NR/All‐on 6, or all‐on 4 2. 16/(76)/NR/all‐on 6, or all‐on‐4 12 months	1. None/none 2. Lateral SFE/Xenograft (Bio‐Oss)	1. No 2. No	A. Prosthesis failure B. Implant failure	Patient‐reported complaints (sinusitis)	No statistically or clinically significant differences were observed between tilted trans‐sinus implants with and without simultaneous bone grafting in the atrophic maxilla
Boven et al. (2017), Netherlands, Case Series, University, Yes	1. Implant‐supported overdenture‐ anterior without SFE 2. Implant‐supported overdenture‐ posterior with SFE	1. 25/150/0/implant‐supported overdenture 2. 25/150/NR/implant‐supported overdenture 5 years	1. NA 2. Lateral SFE with BioOss and autogenous bone. Piezoelectric surgery was employed to minimize the risk of membrane perforation	1. Yes, autogenous (retromolar mandible) and xenograft (Bio‐Oss) particulate 2. Autogenous (lilac crest) block graft + Bio‐Oss	A. Implant survival, changes in marginal bone levels (panoramic radiographs) B. Plaque index C. Calculus score D. Mucosal index E. Bleeding index F. Probing depths	A. Denture satisfaction questionnaire (Vervoorn et al. 1988) B. Chewing ability questionnaire C. Patient satisfaction questionnaire	Six dental implants (placed in the anterior or posterior region) connected with a bar and opposed to natural antagonistic teeth result in acceptable outcomes
Lie et al. (2024), Netherlands, RCT, University, No	1. Implant‐supported overdenture 2. Implant‐supported overdenture 3. Natural Dentition (control group to compare masticatory function)	1. 10/NA/NA/implant‐supported overdenture 2. 10/NA/NA/Implant‐supported overdenture 3. 10/NA/NA/natural dentition 5 years	1. Lateral/Graftless sinus augmentation 2. Lateral/Autogenous + Allograft 3. Crestal/No/No	1. No 2. No 3. No	A. Masticatory performance B. Implant survival C. Peri‐implant health D. Radiographic bone formation.	A. Visual analog scale (VAS) patient satisfaction with prosthesis B. Oral health impact profile (OHIP‐49) C. Quality of masticatory function questionnaire (QMFQ)	Patients with implant‐supported overdentures performed worse in masticatory function compared to those with a natural dentition
Hernández‐ Alfaro et al. (2013), Spain, Case series, University, No	1. 6–10 implants loaded with fixed‐metal‐ceramic restorations	2. 14/108/28/6–10 implants loaded with fixed‐metal‐ceramic restorations 4 months	1. Lateral/A resorbable collagen membrane (Bio‐Gide, Geistlich Pharma) was positioned against the elevated membrane, and the underlying space was filled with demineralized bovine bone particles (Bio‐Oss, Geistlich Pharma)	1. Autograft (Ramus) + small‐particle Bio‐Oss was applied to the buccal wall + Bio‐Gide membranes	A. Implant stability quotients (ISQs) (Osstell Mentor, Integration Diagnostics) B. Volume change (CBCT)	None	Cone beam computed tomographic analysis con‐ firmed substantial volumetric gain and adequate stability at reentry
Kappel et al. (2021), Germany, RCT, University, Yes	Graftless crestal SFE and placement of 4 implants (2 anterior and 2 posterior) and then: (cross‐over design) 1. Loading anterior implants (posterior loading after 3 months) 2. Loading posterior implants (anterior loading after 3 months)	1. 24/96/NR/implant‐supported overdenture 3 years	1. Crestal SFE	1. No	A. Implant survival B. Modified plaque index C. Modified gingival index D. Prosthetic complications	None	Implant survival and success are lower for implants inserted in the edentulous maxilla than in the mandible
Onclin et al. (2023), Netherlands, RCT, University, NA	Lateral SFE using tuberosity bone and organic DBBM (Bio‐Oss, Geistlich) and: 1. 2‐implant overdenture (bar attachment) 2. 4‐implant overdenture (bar attachments)	1. 20/(100)/NA/implant‐supported overdenture 2. 23/(112)/NA/implant‐supported overdenture 5 years	1. Lateral/maxillary tuberosity bone and organic bovine bone (Bio‐Oss, Geistlich) 2. Lateral/maxillary tuberosity bone and organic bovine bone (Bio‐Oss, Geistlich)	1. Maxillary tuberosity bone and organic bovine bone (Bio‐Oss, Geistlich) 2. Maxillary tuberosity bone and organic bovine bone (Bio‐Oss, Geistlich)	A. Marginal bone‐level changes (long cone parallel technique) B. Implant and overdenture survival rate C. Plaque index D. Calculus index E. Probing depth F. Mucosal index G. BOP H. Masticatory performance	A. Denture satisfaction questionnaire B. Dutch version of oral health impact profile (OHIP‐NL49) C. Chewing ability questionnaire	Both groups' clinical and patient‐reported outcome measure scores were equal throughout the entire follow‐up period

FIGURE 3.

Multi‐panel figure of the study, summarizing the timeframe of publications included, frequency of the PROMs and ClinROs assessed as well as the comparison of the number of the articles including PROMs in addition to ClinROs. ChA Q, chewing ability questionnaire; DSQ, denture satisfaction questionnaire; N, number; QMFQ, quality of masticatory function questionnaire; VAS, visual analog scale.

3.3. Qualitative Assessment

3.3.1. Patient‐Reported Outcome Measures (PROMs) and Clinician‐Reported Outcomes (ClinROs) Used in the Included Studies

A qualitative assessment was performed on the included studies, identifying PROMs and ClinROs used. These were later categorized.

3.3.1.1. Patient‐Reported Outcome Measures (PROMs)

PROMs were reported in 9 (Rickert et al. 2014; Putters et al. 2019; Boven et al. 2020, 2017; Slot et al. 2019; Grandi et al. 2019; Lie et al. 2024; Onclin et al. 2023; Aly and Hammouda 2017) of the included studies (50%). The seven PROMs identified (Table 2) are described below:

• Quality of masticatory function questionnaire (QMFQ): This PROM was introduced by Muller et al. (2008). One of the included studies (11.1%) (Lie et al. 2024) implemented this tool to report the quality of masticatory function. This consists of 29 questions divided into six domains: chewing ability, prosthesis, habits, meats, vegetables, and fruits.

• Quality of life questionnaire via Oral Health Impact Profile (OHIP) (OHIP‐49, OHIP‐EDENT, and OHIP‐49NL): The OHIP questionnaire was used in three studies (33.3%). Specifically, OHIP‐49 (49 questions covering seven domains) was used in two studies (Boven et al. 2020; Onclin et al. 2023). The 20‐question shortened version of this questionnaire which is modified for edentulous patients was used in one study (Lie et al. 2024). Moreover, Onclin et al. 2023 used a validated Dutch version of this PROM.

• Visual analog scale (VAS): Among the included studies, the studies by Putters et al. (2019), Lie et al. (2024), and Aly and Hammouda (2017), (33.3%) used the VAS scale for assessment of pain levels. This consists of a 0 to 10 scale (“no pain” to “worst pain ever experienced”).

• Denture satisfaction questionnaire (DSQ): Originally introduced by Vervoorn et al. (1988), this questionnaire consists of 40 questions concerning complaints related to dentures. Four of the included studies used this PROM (Boven et al. 2020, 2017; Slot et al. 2019; Onclin et al. 2023) (44.4%).

• Chewing ability questionnaire: This tool was introduced in 2005 by Stellingsma et al. (2005). This questionnaire assesses patients' opinions about the ability to chew nine different types of food (soft, tough, and hard) on a 3‐point scale. Three studies used this scale (Slot et al. 2019; Boven et al. 2017; Onclin et al. 2023) (33.3%).

• Patient's overall satisfaction with denture: Three studies (Rickert et al. 2014; Boven et al. 2020, 2017) (33.3%) used a ten‐point scale to evaluate patients' overall satisfaction with the denture.

• Patient‐reported complaints: The study by Grandi et al. (2019), (11.1%) assessed patients' complaints (presence of sinusitis) in the follow‐up visits.

TABLE 2.

Complete description of the implemented PROMs in the included studies, along with the original reference where the PROM was introduced.

PROM/references used	Original reference	Description
Visual analog scale (VAS) for pain (Putters et al. 2019; Lie et al. 2024)	Miller and Ferris (1993)	The pain level scale ranged from 0 (no pain) to 10 (worst pain ever experienced)
Denture satisfaction questionnaire (Rickert et al. 2014; Boven et al. 2020, 2017; Onclin et al. 2023)	Vervoorn et al. (1988)	The denture complaint questionnaire, contains 40 complaints about the denture: 1A. Functional complaints of the maxillary denture; this is the total score of 12 complaints concerning the upper denture 1B. Functional complaints of the mandibular denture: this is the total score of 8 complaints concerning the lower denture. 1C. Vague denture complaints:this is the total score of 11 vague complaints not specifically related to the maxillary or mandibular denture. 1D. Aesthetic complaints: “too hollow,” this is the total score of 5 complaints related to a hollow face 1E. Aesthetic complaints “Too bulbous,” this is the total score of 4 complaints related to a bulbous face 2. General satisfaction 3. Satisfaction with maxillary denture 4. Satisfaction with mandibular denture 5. Aesthetic satisfaction 6. Satisfaction with retention 7. Functional satisfaction 8. The “denture satisfaction score,” this is the total score of variables 2–7 9. The “denture quality score,” this is the total score of the 9 denture quality variables 10. Number of years with present dentures 11. Number of years with complete dentures 12. Number of previous complete maxillary dentures 13. Number of previous complete mandibular dentures 14. Age 15. Sex The items of variable 1 were rated on a four‐point scale by the subjects themselves (0 = not at all;1 = a little;2 = quite a lot; 3 = extremely). The variables 2–7 were rated on a five‐point scale by the subjects themselves (0 = very satisfied; 1 = satisfied; 2 = neither satisfied nor dissatisfied; 3 = dis‐ satisfied; 4 = very dissatisfied)
Oral health impact profile (OHIP‐49) (Boven et al. 2020; Lie et al. 2024; Onclin et al. 2023)	Slade and Spencer (1994)	This questionnaire consists of 49 items covering seven domains: 1. Functional limitation 2. Physical pain 3. Psychological discomfort 4. Physical disability 5. Psychological disability 6. Social disability 7. Handicap The severity of a complaint could be expressed on a five‐point rating (0: never, 1: rarely, 2: sometimes, 3: often, 4: very often) The total OHIP‐49 score ranges between 0 and 196 points The separate domain scores give an impression of the level at which the effects of the oral problem manifest themselves A lower score indicates a better oral health‐related quality of life (OHRQoL)
Chewing ability questionnaire (Slot et al. 2019; Onclin et al. 2023)	Stellingsma et al. (2005)	In this questionnaire, patients give their opinion about the ability to chew nine different kinds of food on a 3‐point rating scale (0 = good, 1 = moderate, and 2 = bad). The items are grouped into three scales: soft food, tough food, and hard food. In addition to these questionnaires, the patients' overall denture satisfaction is expressed on a 10‐point rating scale (1 = very bad to 10 = excellent).
Oral health impact profile‐20E (OHIP‐20E)	Allen and Locker (2002)	Seven domains and 20 questions, and for each question the patient had to give a score. (this is a shorter version of OHIP‐49; modified for edentulous patients) The frequency ranges between 1 (always) to 6 (never), and the questions are related to: 1. Functional limitation 2. Physical pain 3. Psychological discomfort 4. Physical disability 5. Psychological discomfort 6. Social disability 7. Handicap
Quality of masticatory function questionnaire (QMFQ) (Lie et al. 2024)	Muller et al. (2008)	This questionnaire consists of 29 questions divided into six domains: 1. Chewing ability 2. Prosthesis 3. Habits 4. Meats 5. Vegetables 6. Fruit Responses are recorded on a 5‐point Likert scale, with questions related to chewing ability (1 = always problems/major difficulties, 5 = never problems/no difficulties). 1. Do you have difficulty chewing small pieces of beef? 2. Do you have difficulty chewing small pieces of chicken? 3. Do you have difficulty chewing ground beef? 4. Do you have difficulty chewing hard, raw vegetables, without cutting them? 5. Do you have difficulty chewing hard, raw fruits, without cutting them (e.g., apples)? 6. Do you have difficulty chewing hard, raw fruits, after cutting them in quarters? 7. Do you have difficulty chewing peels of hard raw fruits? 8. Do you have difficulty chewing crusted bread? 9. Do you have difficulty chewing nuts and grains? 10. Do you have difficulty chewing with your prosthesis? 11. Do you have to remove one or both of your prostheses in order to eat? 12. Do you have to drink while eating to facilitate swallowing? 13. Do you have to add sauce to your meal to facilitate swallowing? 14. Do you have to soak your food to facilitate chewing and/or swallowing? 15. Is your food choice limited because of your prosthesis? 16. In general, is the food well chewed before being swallowed? 17. Have you eaten beef cut into small pieces? 18. Has it been necessary to ground the beef before eating? 19. Have you eaten chicken cut into small pieces? 20. Has it been necessary to ground the chicken before eating? 21. Has it been necessary to convert meat into puree in order to eat? 22. Have you eaten fresh apples without cutting them? 23. Is it necessary to peel the apples before eating? 24. Is it necessary to cut the apples into quarters in order to chew them? 25. Is it necessary to cut the apples into small pieces in order to chew them? 26. Has it been necessary to convert fruits into puree in order to eat? 27. Have you eaten fresh carrots without cutting them? 28. Is it necessary to cut the carrots into small pieces in order to eat?
Overall denture satisfaction score (Rickert et al. 2014; Boven et al. 2020)	Not clear	Overall denture satisfaction through the General Satisfaction Score (GSS) with the upper or lower denture a ten‐point rating scale (1: very bad to 10: excellent)

3.3.1.2. Clinician‐Reported Outcomes (ClinROs)

The ClinROs were assessed and presented by the clinicians within the included studies. 100% of the included studies reported ClinROs (18/18). These are further categorized as follows, based on the main method of assessing.

3.3.1.2.1. Clinical Outcomes

1. Implant survival: This was the most widely reported ClinRO among the included studies (11/18; 61.11%) (Lie et al. 2021; Boven et al. 2020, 2017; Wortmann et al. 2021; Mordenfeld et al. 2016; Urban et al. 2017; Xavier et al. 2015; Slot et al. 2019; Grandi et al. 2019; Kappel et al. 2021; Onclin et al. 2023). Urban et al. followed the PISA consensus criteria (Misch et al. 2008) while other studies simply considered an implant failed if implant mobility was detected. This was performed by checking the mobility of implants after removal of the bar at each evaluation period (if bar‐retained prostheses were used) and scoring the loose and lost implants to calculate the implant survival rate.

2. Prosthesis (overdenture) survival: Two studies (11.11%) reported prosthesis survival (Slot et al. 2019; Onclin et al. 2023). Slot et al. (2019) defined prosthesis failure if it needed to be replaced for any reason. While Onclin et al. (2023) defined the survival rate of prostheses as the percentage of the initially placed overdentures still present at the follow‐up.

3. Presence of plaque, calculus, and bleeding: The three indexes of Gingival index Loe and Silness (1963), bleeding index, and plaque index (Mombelli et al. 1987) were used for this purpose in six trials (Rickert et al. 2014; Slot et al. 2019; Boven et al. 2017; Kappel et al. 2021; Onclin et al. 2023; Mombelli et al. 1987) (33.3%).

4. Probing depth: Five of the included studies (Rickert et al. 2014; Boven et al. 2020, 2017; Slot et al. 2019; Onclin et al. 2023) (27.7%) directly reported probing depth outcomes. It should be noted that in some cases, probing depth was indirectly taken into consideration when reporting the incidence of peri‐implant diseases. This mainly was determined using a periodontal probe from 6 sites around each implant, and all depths were noted to the nearest millimeter on the probe.

5. Implant insertion torque and stability: Three studies (Putters et al. 2019; Hernández‐ Alfaro et al. 2013; Aly and Hammouda 2017) (16.6%) reported implant insertion torque/stability. Implant stability quotient (ISQ) levels were checked using the Osstell device (Integration Diagnostic AB, Savedalen, Sweden).

6. Implant success: This was assessed using different definitions among four of the included trials (Lie et al. 2021; Mordenfeld et al. 2016; Kappel et al. 2021; Aly and Hammouda 2017) (22.2%). Aly and Hammouda (2017), Lie et al. (2021), Mordenfeld et al. (2016), used Albrektsson and Zarb's criteria (Albrektsson et al. 1986). While Kappel et al. (2021), defined success as clinical stability and immobility, full functionality, absence of pain on light percussion, healthy peri‐implant soft tissue on probing, and absence of radiolucency or other radiographic pathologic conditions.

7. The success of prosthetic rehabilitation: In two studies (11.1%), prosthetic success was also assessed (Lie et al. 2021; Mordenfeld et al. 2016). Lie et al. defined this as: a fully functional prosthesis without any vertical positional change, with a perfect fit and no occlusal disturbances. Moreover, Mordenfeld et al. used Albrektsson's prosthesis success criteria (Albrektsson et al. 1986).

8. Masticatory performance: Two studies Lie et al. (2024) and Onclin et al. (2023) (11.1%) reported masticatory performance as one of the main clinical outcomes. They used a two‐layer wax, with the colors red and blue, and the total thickness was 3 mm, with a diameter of 30 mm. The outcome variable was called the Mixing Ability Index (MAI) and ranged between 5 and 30, where a lower MAI score implied a better‐mixed tablet and better masticatory performance. Subjects were asked to chew on this tablet 20 times in order to mix the two colors. The tablet was then flattened, pressed to a thickness of 2 mm, and scanned on both sides using a high‐quality scanner, and the scanned images were processed using Adobe Photoshop CS3 extended (Adobe, San Jose, CA, USA). The spread of the color intensities was measured, and a mixing ability score was calculated.

3.3.1.2.2. Imaging Outcomes

1. Maxillary sinus bone height/volume changes: In five trials (Lie et al. 2021; Macedo et al. 2021; Castagna et al. 2013; Mordenfeld et al. 2016; Hernández‐ Alfaro et al. 2013) (27.7%) the outcomes of SFE, in terms of the radiographical bone gain/change, were assessed. Macedo et al. and Hernández‐Alfaro et al. used CBCT scans to assess sinus height and volume changes, respectively. Castagna et al. and Lie et al. assessed horizontal and vertical bone gain using CBCT scans. In contrast, the study by Mordenfeld 2016 implemented panoramic X‐rays to assess the grafted sinus area.

2. Peri‐implant bone‐level changes: Nine studies (50%) assessed peri‐implant marginal bone levels and their changes over time (Rickert et al. 2014; Putters et al. 2019; Boven et al. 2020, 2017; Mordenfeld et al. 2016; Urban et al. 2017; Slot et al. 2019; Grandi et al. 2019; Aly and Hammouda 2017). Mainly these can be categorized into the studies where a parallel standardized peri‐apical image (Rickert et al. 2014; Mordenfeld et al. 2016; Urban et al. 2017; Slot et al. 2019; Grandi et al. 2019) or panoramic images (Putters et al. 2019; Boven et al. 2020, 2017; Aly and Hammouda 2017) were used.

3.3.1.2.3. Histological Outcomes

Histological outcomes through bone biopsies were assessed by three studies (Putters et al. 2019; Wortmann et al. 2021; Xavier et al. 2015) (16.6%). Putters et al. (2019), evaluated mineralized tissue and newly formed bone through bone biopsies from the reconstructed maxillae at the 4‐month follow‐up as well as the donor sites at the baseline. The outcomes of interest were bone percentage (Bp), osteoid percentage (Op), and osteocyte number per volume (OcN/Ba). Likewise, Wortmann et al. (2021), conducted microcomputed tomography analysis of tissue mineral density (TMD), bone mineral density (BMD), and bone volume fraction (BVF) in biopsies taken from fresh anterior iliac crest and calvarial bone grafts from reconstructed maxillary alveolar ridges with either of these bone grafts 4 months after reconstruction and prior to implant placement. Moreover, they also performed a histomorphometric analysis of Bp, Op, and OcN/Ba in biopsies from freshly harvested bone grafts and from the grafted sites after 4 months in the patients undergoing reconstruction of the edentulous maxilla prior to implant placement. Lastly, Xavier et al. (2015), assessed the percentage of connective tissue, new bone, and residual graft particles.

3.3.1.2.4. Safety Outcomes

1. Incidence of peri‐implant diseases: Presence of peri‐implant mucositis and/or peri‐implantitis was assessed in three studies (Slot et al. 2019; Grandi et al. 2019; Onclin et al. 2023) (16.6%). Slot et al. used the seventh European workshop on periodontology criteria (Lang and Berglundh 2011) while Onclin et al. followed the newer criteria (2017 World Workshop) (Berglundh et al. 2018).

2. Morbidity and surgery‐related complications: Four studies (Rickert et al. 2014; Castagna et al. 2013; Putters et al. 2019; Wortmann et al. 2019) (22.2%) reported surgery‐related complications and patient morbidity. Castagna et al., defined this outcome as “Infection requiring re‐entry or antibiotic intervention (yes/no)” (Castagna et al. 2013). Studies by Putters et al. (2019) and Wortmann et al. (2019) assessed peri‐operative complications (such as sinus membrane perforation and wound dehiscence).

3. Prosthetic complications: Two trials (Kappel et al. 2021; Onclin et al. 2023) reported this ClinRO(11.1%) and mainly included loosening of denture teeth, replacement or tightening of nylon caps or gold clips due to retention loss, and adaptation of the denture edges because of pressure ulcers.

3.3.1.3. Follow‐Up Duration of Reported PROMs and ClinROs

The follow‐up period in the studies included ranged from 4 months to 15 years. Among the studies reporting PROMs, the follow‐up duration ranged from at least 1 to 5 years, with the exception of one study by Putters et al. (2019), which assessed pain using a VAS scale 4 months postoperatively. Studies with shorter follow‐up periods (4–12 months) primarily focused on ClinROs, particularly histological outcomes and/or short‐term augmentation outcomes prior to implant placement.

ClinROs were assessed at various follow‐up periods across the included studies. Short‐term outcomes (≤ 6 months) primarily focused on bone‐related parameters, including vertical bone gain, maxillary sinus height, bone resorption percentage, and histological (biopsy) or radiographic bone‐level changes (CBCT or peri‐apical). Additionally, primary stability, wound dehiscence, and implant stability (ISQ) were evaluated within 4–6 months (Lie et al. 2021; Macedo et al. 2021; Castagna et al. 2013; Putters et al. 2019; Wortmann et al. 2021; Xavier et al. 2015; Hernández‐ Alfaro et al. 2013). At 12 months, studies commonly reported peri‐implant parameters such as plaque index, gingival inflammation (GI, sBI), PDs, mucosal health, and marginal bone levels, alongside implant and prosthesis survival rates (Rickert et al. 2014; Boven et al. 2020; Grandi et al. 2019). Mid‐term follow‐ups (18 months to 3 years) continued to assess implant survival, success rates, and MBL, with additional reports on prosthetic complications and masticatory performance at 3 years (Kappel et al. 2021). Long‐term assessments (5 years or more) consistently examined implant survival, success, MBL, and grafted sinus height, along with peri‐implant health parameters such as PI, calculus accumulation, mucosal indices, and radiographic bone levels (Mordenfeld et al. 2016; Slot et al. 2019; Boven et al. 2017; Lie et al. 2024; Onclin et al. 2023). A study spanning 1 to 15 years also tracked implant survival, bone gain, and MBL over time (Urban et al. 2017).

3.3.2. COSMIN Analysis on Included PROMs

This systematic review included the evaluation of seven PROMs using the COSMIN checklist. The PROMs analyzed were the quality of masticatory function questionnaire (QMFQ), OHIP‐20E (OHIP‐EDENT‐19), OHIP‐49, VAS, DSQ, chewing ability questionnaire, Patient's overall satisfaction with denture questionnaire, and patient‐reported complaints. Table 3 presents the COSMIN checklist scores evaluating the methodological quality of each study and reporting the assessment of the measurement properties per PROM. Also, Figure 4 presents the radar plots of the COSMIN scores of each of the identified PROMs. The complete description of the COSMIN scores with regard to each of the domains assessed is described in the Appendix S1.

TABLE 3.

The COSMIN analysis results for each of the included PROMs and their corresponding score, demarcated by background color in each cell (Green: Very good, Light green: Adequate, Yellow: Not applicable, Light red: Doubtful, Red: Inadequate).

PROM/References used	Domain
	PROM development	Content validity	Structural validity	Internal consistency	Cross‐cultural validity/measurement invariance	Reliability	Measurement error	Criterion validity	Hypotheses testing for construct validity	Responsiveness
Quality of masticatory function questionnaire (QMFQ) (Muller et al. 2008; Hilasaca‐Mamani et al. 2016)	Very good	Very good	Adequate	Very good	Adequate	Very good	Not applicable	Not applicable	Very good	Very good
OHIP‐20E (OHIP‐EDENT‐19) (Allen and Locker 2002)	Very good	Very good	Doubtful	Doubtful	Very good	Very good	Not applicable	Not applicable	Very good	Very good
OHIP‐49 (OHIP‐NL) (van der Meulen et al. 2008)	Very good	Very good	Very good	Very good	Very good	Very good	Not applicable	Not applicable	Very good	Very good
VAS (Huskisson 1974; McCormack et al. 1988)	Very good	Very good	Not applicable	Not applicable	Very good	Very good	Very good	Very good	Very good	Very good
Denture satisfaction questionnaire (Vervoorn et al. 1988; Osman et al. 2018; Santucci et al. 2014)	Very good	Very good	Very good	Very good	Very good	Very good	Not applicable	Very good	Very good	Very good
Chewing ability questionnaire (Stellingsma et al. 2005)	Very good	Very good	Very good	Very good	Not applicable	Very good	Not applicable	Not applicable	Very good	Very good
Patient's overall satisfaction with denture (Slot et al. 2016, 2023)	Inadequate	Inadequate	Not applicable	Not applicable	Not applicable	Inadequate	Not applicable	Not applicable	Inadequate	Adequate
Patient‐reported complaints	Inadequate	Inadequate	Inadequate	Inadequate	Inadequate	Inadequate	Inadequate	Inadequate	Inadequate	Adequate

FIGURE 4.

Radar plot indicated the performance of each of the included PROMs in this systematic review, based on the performed COSMIN analysis. Note that each domain was scored separately (inadequate =1 to very good =5).

3.4. Treatment Outcomes in Included Studies

(PROMs and ClinROs) (See Appendix S1).

4. Discussion

4.1. Summary of Main Findings

In this systematic review, PROMs and ClinROs used in clinical studies published in the last 10 years on SFE in edentulous patients were identified and assessed. Additionally, the quality and robustness of the available PROMs were assessed. The results indicated four main domains in ClinROs, including clinical (9 measures), imaging (2 measures), histological, and safety (2 measures) outcomes. The most widely reported ClinRO was implant survival (61.11%), followed by radiographical peri‐implant bone‐level changes (50%). Conversely, ClinROs such as maxillary bone height changes (27.7%), histology (16.6%), and sinus membrane perforation (reported in approximately 10% of included studies), which are directly related to SFE procedures, were reported less frequently compared to those mentioned previously. This mainly indicates that the current ClinROs in SFE in edentulous patients are more inclined toward reporting the final implant outcomes rather than outcomes assessing SFE. Additionally, due to the inclusion of subjects with complete edentulism, special emphasis on final rehabilitation outcomes (such as masticatory function, esthetics, etc.) is needed. This was reflected in only 11.11% (overdenture survival and success of prosthetic rehabilitation, prosthetic complications, and masticatory performance) of the included studies. This generally points out that ClinROs in SFE in these studies are more focused on implant‐related outcomes rather than prosthetic‐related outcomes.

When it comes to the PROMs included in the studies, seven measures were identified. The most frequently reported outcomes were OHIP (OHIP‐49, OHIP‐EDENT/OHIP‐20E) and DSQ, which were reported in 44.4% and 33.3% of the included studies, respectively. In addition to DSQ, the presence of the chewing ability questionnaire as well as QMFQ indicates that, compared to the ClinROs, there is a greater focus in PROMs on assessing edentulous patients' masticatory function. This focus aligns with the primary objective of implant therapy in these subjects (rehabilitation of masticatory function).

The COSMIN analysis provided valuable insights into the methodological quality of the included PROMs. Among the PROMs analyzed, the OHIP‐49 and DSQ emerged as the most robust measures. Both demonstrated “very good” ratings across multiple COSMIN domains. These findings are in line with previous studies, which consistently support the strong psychometric properties of OHIP‐49 (Anagnostopoulos 2014). Studies have shown that OHIP‐49 has excellent internal consistency (Cronbach's alpha ranging from 0.89 to 0.97) and test–retest reliability, making it a reliable tool for assessing oral health‐related quality of life in diverse populations (Kuo et al. 2011). Additionally, OHIP‐49 has demonstrated conceptual validity through path analysis, aligning with Locker's model of oral health‐related quality of life (Grecu et al. 2020). Despite its length, research suggests it remains a comprehensive tool, with studies confirming its reliability even in medically complex populations, such as individuals with systemic sclerosis (Yuen and Nelson 2014). Moreover, its use in longitudinal studies has shown its sensitivity to detecting improvements in oral health‐related quality of life following implant therapy (Filius et al. 2018). Moreover, the VAS tool also received high ratings in reliability, content validity, and responsiveness, highlighting its utility in capturing PROMs, specifically in measuring pain and overall satisfaction. The straightforward, single‐item nature of VAS makes it a practical and efficient tool in both clinical and research settings (Bijur et al. 2001; Boonstra et al. 2008). However, its applicability in assessing more complex constructs is limited compared to multi‐item PROMs such as OHIP‐49. The chewing ability questionnaire and QMFQ both scored “very good” in several domains, particularly in hypotheses testing for construct validity and responsiveness. These measures are particularly valuable in assessing masticatory function, which is a critical outcome for edentulous patients undergoing implant therapy. Despite their strengths, there are areas for improvement, particularly in the QMFQ's structural and cross‐cultural validity, which were rated as “adequate.” This suggests that further refinement is needed to enhance its factor structure. The weakest PROMs, the patient's overall satisfaction with denture questionnaire and patient‐reported complaints, were introduced as customized measures in the included articles and are not internationally validated tools like VAS or DSQ. This lack of standardization and validation likely contributes to their inadequate ratings across multiple domains. The importance of using well‐validated PROMs is well‐documented in clinical research as it ensures the reliability, validity, and generalizability of the measurements. Validated PROMs are critical for accurately capturing patient outcomes and ensuring the integrity of research findings (O'Donovan et al. 2022; Kim et al. 2023). While this review systematically identified PROMs and ClinROs reported in studies on SFE in the completely edentulous maxilla, it should be acknowledged that these are not the only measures relevant to this field. For instance, widely used PROMs such as OHIP‐14 (Tosun and Uysal 2024; El Osta et al. 2021; Bana et al. 2021), which is well‐documented in the dental literature for assessing oral health‐related quality of life in edentulous patients, were not commonly reported in the included studies. This highlights a potential gap in standardized PROM utilization and suggests the need for future research to assess the applicability of established tools in this specific population.

Another crucial factor in assessing outcome measures is the follow‐up duration at which outcomes are reported. Our findings indicate that most studies reporting PROMs had a follow‐up period of 1–5 years, reflecting a moderate‐to‐long‐term timeline. In contrast, longer follow‐ups (over 5 years) primarily assessed clinical outcomes such as implant survival rates. Short‐term follow‐ups (< 1 year) predominantly included histological outcomes—typically assessed before implant placement due to ethical considerations—or PROMs related to early healing, such as pain scores and medication intake. The ideal timepoint for assessing outcomes depends on their nature. Short‐term assessments are appropriate for pain and histological outcomes, while long‐term evaluations are necessary for implant success, survival, quality of life, and cost‐effectiveness of SFE procedures. While the studies included generally followed this pattern, the limited number of available studies restricts the ability to draw definitive conclusions.

Lastly, the timeline of our search strategy, limited to the past 10 years, should be acknowledged. While literature suggests that PROMs have been increasingly incorporated into clinical studies in this field, some earlier studies also reported PROMs. For example, Pieri et al. (2012) assessed patient‐reported pain and swelling within 1 week after bilateral lateral SFE in the edentulous maxilla. Additionally, after 1 year of functional loading, they used a self‐administered questionnaire to evaluate satisfaction with function, chewing comfort, esthetics, speech ability, and ease of cleaning, with responses rated on a verbal scale (excellent, good, sufficient, or poor). Similarly, Felice et al. (2011) employed a three‐question survey on function, esthetics, and willingness to undergo the same surgery, administered 5 months post‐loading following bilateral SFE with simultaneous autogenous block grafting. Other studies utilized VAS scales to assess overall satisfaction (Visser et al. 2009). While these earlier reports contribute valuable insights, the use of standardized scales such as OHIP or DSQ appears to have become more prevalent in the past decade, reflecting a shift toward more structured PROM assessments.

4.2. Outcomes of SFE in the Edentulous Maxilla (Appendix S1)

4.2.1. Recommendations

4.2.1.1. Improvement of PROMs

The patient's overall satisfaction with denture questionnaire and patient‐reported complaints showed significant limitations in validity and reliability. Future research should focus on enhancing the structural validity and internal consistency of these PROMs to ensure they accurately reflect patient experiences and outcomes. Developing standardized, validated PROMs specific to SFE procedures is essential for capturing patient perspectives more effectively. In particular, current PROMs may lack key postoperative sequelae relevant to SFE, such as pain, swelling, recovery time, and return to normal function or work. Since these aspects are important considerations for patients, future studies should explore their inclusion in PROMs to provide a more comprehensive assessment of patient‐reported recovery and satisfaction. Developing standardized, validated PROMs specific to SFE procedures will be essential in capturing patient perspectives more effectively.

4.2.1.2. Incorporation of SFE‐Specific ClinROs

Studies focusing on SFE should incorporate ClinROs that directly relate to SFE outcomes. Specific measures such as clinical bone height/volume changes, histological outcomes, and surgery‐related complications need to be systematically included and reported to provide a comprehensive assessment of these interventions. This will help in understanding the direct impact of SFE procedures on clinical outcomes.

4.2.1.3. Early Healing and Long‐Term PROMs

In addition to final prosthetic PROMs, there is a need for early healing PROMs. There should be an initial set of PROMs assessing pain, discomfort, and overall experience immediately after SFE procedures. Subsequently, in the long term, PROMs should assess chewing function, esthetics, overall psychological satisfaction, and the impact of the final prosthesis on the patient's quality of life. This dual‐phase approach will provide a more holistic understanding of patient outcomes throughout the treatment process.

4.2.1.4. Standardization of PROMs and ClinROs Reporting

There is a clear need for a standardized protocol on which tools should be used regularly in studies involving SFE in the fully edentulous maxilla. The lack of standardization hampers comparability and the synthesis of evidence. For policymakers and researchers, it is crucial to establish and implement standardized tools for both ClinROs and PROMs to ensure consistency and reliability across studies. Whenever possible, it is better to use validated and internationally standardized PROMs, rather than ad hoc measures like patient complaints and overall satisfaction, which were introduced in the articles later. This standardization will facilitate the integration of findings and the development of best practices in clinical research and patient care.

4.3. Limitations

Despite the comprehensive nature of this systematic review, several limitations should be acknowledged. First, while the review included an acceptable number of studies (18), the heterogeneity among these studies in terms of population, type of materials used, and outcomes assessed may affect the generalizability of the findings. Additionally, the focus on studies published between 2013 and 2024, while ensuring the inclusion of the most recent research, may have resulted in the exclusion of relevant older studies that could provide a broader perspective. Lastly, the customized nature of some PROMs, which were not internationally validated, introduces variability and potential bias in the assessment of PROs, potentially affecting the consistency and comparability of the results.

5. Conclusions

This systematic review assessed, summarized, and analyzed the characteristics and features of PROMs and ClinROs in clinical studies focusing on SFE in the fully edentulous maxilla. The most robust PROMs, as demonstrated by the COSMIN analysis, were the OHIP‐49 and DSQ, showing strong psychometric properties across multiple domains. The most widely used ClinROs were implant survival (reported in 61.11% of studies) and peri‐implant bone‐level changes (50%). Conversely, less attention was given to ClinROs directly related to SFE, such as maxillary bone height/volume changes and sinus membrane perforation, indicating inadequacy in these crucial outcome measures. Future recommendations for researchers and policymakers were drawn, emphasizing the need for validated and standardized PROMs and ClinROs to ensure consistency and reliability in outcome assessment.

Author Contributions

Hamoun Sabri: methodology, formal analysis, writing – original draft, conceptualization. Muhammad H. A. Saleh: conceptualization, writing – review and editing, project administration, supervision. Jacob Martin Zimmer: data curation, writing – original draft. Frank Schwarz: supervision. Hom‐Lay Wang: supervision, writing – review and editing.

Conflicts of Interest

The authors declare no conflicts of interest.

Supporting information

Appendix S1

Data Availability Statement

The original data regarding this study will be provided upon reasonable request from the first or corresponding author.