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. 2024 Aug 7;35(12):1655–1668. doi: 10.1111/clr.14340

Alveolar bone regeneration using a 3D‐printed patient‐specific resorbable scaffold for dental implant placement: A case report

Sašo Ivanovski 1,2,✉, Reuben Staples 1,2, Himanshu Arora 1,2, Cedryck Vaquette 1,2, Jamil Alayan 1,2
PMCID: PMC11629455  PMID: 39109582

Abstract

Background

This case report demonstrates the effective clinical application of a 3D‐printed, patient‐specific polycaprolactone (PCL) resorbable scaffold for staged alveolar bone augmentation.

Objective

To evaluate the effectiveness of a 3D‐printed PCL scaffold in facilitating alveolar bone regeneration and subsequent dental implant placement.

Materials and Methods

A 46‐year‐old man with a missing tooth (11) underwent staged alveolar bone augmentation using a patient‐specific PCL scaffold. Volumetric bone gain and implant stability were assessed. Histological analysis was conducted to evaluate new bone formation and graft integration.

Results

The novel approach resulted in a volumetric bone gain of 364.69 ± 2.53 mm3, sufficient to reconstruct the original alveolar bone contour and permit dental implant placement. Histological analysis showed new bone presence and successful graft integration across all defect zones (coronal, medial, and apical), with continuous new bone formation around and between graft particles. The dental implant achieved primary stability at 35 Ncm−1, indicating the scaffold's effectiveness in promoting bone regeneration and supporting implant therapy. The post‐grafting planned implant position deviated overall by 2.4° compared with the initial restoratively driven implant plan pre‐bone augmentation surgery. The patient reported low average daily pain during the first 48 h and no pain from Day 3.

Conclusions

This proof‐of‐concept underscores the potential of 3D‐printed scaffolds in personalized dental reconstruction and alveolar bone regeneration. It marks a significant step forward in integrating additive manufacturing technologies into clinical practice through a scaffold‐guided bone regeneration (SGBR) approach. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000118707p).

Keywords: 3D printing, case report, guided bone regeneration, Polycaprolactone, scaffold‐guided bone regeneration

1. INTRODUCTION

Staged alveolar augmentation is a highly demanding procedure frequently required during dental implant rehabilitation to overcome major deficiencies in edentulous ridges (Jepsen et al., 2019). Whilst various staged bone augmentation modalities have been successfully utilized, resulting in high 5‐year dental implant survival rates, it is generally accepted that an ideal approach is not available, especially in the case of large volume defects (Naenni et al., 2019; Urban et al., 2019). Guided bone regeneration (GBR) is the most commonly reported modality for staged alveolar ridge augmentation (Jepsen et al., 2019) and includes the use of both resorbable and non‐resorbable membranes/barriers covering various particulate bone grafts. Traditional GBR techniques however are associated with a number of drawbacks such as the need for chairside membrane shaping and trimming, the need for second stage removal in the case of non‐resorbable membranes, limited space maintenance capabilities especially for non‐resorbable membranes, and high rates of wound dehiscence (Garcia et al., 2018; Lim et al., 2018; Machtei, 2001; Urban et al., 2019).

More recently, additive manufacturing, commonly referred to as three‐dimensional (3D) printing technology, has been used in the fabrication of patient‐specific meshes, fabricated using titanium, for regenerating alveolar ridge defects (Chiapasco et al., 2021; Dellavia et al., 2021; Ivanovski et al., 2023). These devices have shown promising results, but have inherent disadvantages due to their non‐resorbable nature, including the requirement for surgical removal. Medical grade polymers, such as polycaprolactone (PCL) are emerging as a promising alternative due to their biocompatibility, resorbable nature (Hwang et al., 2023; Rasperini et al., 2015; Vaquette et al., 2021, 2022), accuracy (Bartnikowski et al., 2020) and dimensional stability following implantation (Vaquette et al., 2021).

The aim of this case report was to provide a proof of concept illustrating the effectiveness of a 3D‐printed, patient‐specific scaffold fabricated from medical grade PCL for staged alveolar bone augmentation to facilitate subsequent dental implant placement. To the best of our knowledge, this is the first clinical report successfully utilizing this technology for scaffold‐guided bone regeneration (SGBR) of alveolar bone for dental reconstruction.

2. CLINICAL PRESENTATION AND ASSESSMENT

A 46‐year‐old male patient was referred to a specialist periodontal practice in Brisbane, Australia for dental implant replacement of his upper right central incisor (11). He had no significant medical conditions, no allergies and was a non‐smoker. On examination there were no obvious dental abnormalities. A periodontal assessment indicated healthy probing pocket depths (<3 mm) with a full mouth plaque score of 4.2% and full mouth bleeding score of 1.2%. Site level assessment of tooth 11 indicated evidence of inflammation and a buccal fistula. Radiographically, evidence of a previous root canal treatment and a post‐core crown was noted. In addition, a peri‐apical radiolucency was obvious consistent with inflammatory pathology. The decision was made to remove tooth 11 followed by further detailed assessment aimed at restoring it with an implant supported restoration. After removal of tooth 11 without incident, a cone beam CT (CBCT1) scan was obtained confirming the site exhibited a large horizontal alveolar ridge defect that prevented the possibility of achieving primary stability of a dental implant in a restoratively driven position (type‐4; Benic & Hammerle, 2014; Figure 1a–c). After further discussions with the patient, a decision was taken to carry out staged ridge augmentation, followed by implant placement after 6 months. Furthermore, the patient consented to the use of a patient‐specific 3D‐printed PCL scaffold for the augmentation procedure.

FIGURE 1.

FIGURE 1

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Development process of the patient‐specific scaffold from initial CBCT to packaged device. (a–c) Cross‐sectional CBCT images displaying coronal, sagittal and axial views. (d) Conversion of the patient's defect into an STL file. (e) Schematic representation of the patient‐specific scaffold in STL format. (f) Fitting of the scaffold over the implant planning model to verify design accuracy. (g, h) 3D printing of the patient‐specific scaffold. (j) Fitting of the patient‐specific scaffold prototype onto the 3D‐printed surgical planning model. (i) Final packaging of the Gamma‐irradiated scaffold in a gamma‐safe, thermo‐sealed and labelled chevron pouch.

2.1. Ethics and consent

The use of a patient‐specific 3D‐printed PCL scaffold for this patient is part of a larger clinical trial of this technology, with ethics approval obtained from the University of Queensland Human Research Ethics Committee (project number: 2021/HE002272) and the Uniting Health Care human research ethics committee (project number: 202211). This project also complies with the provisions contained in the National Statement on Ethical Conduct in Human Research (NHMRC 2007 updated in 2018) and with the regulations governing experimentation on humans. This trial was conducted under the Australian Therapeutic Good Administration (TGA) Clinical Trial Notification (CTN) scheme and was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000118707p) on 25th of January 2022.

3. METHODOLOGY

3.1. Pre‐operative planning and anatomical model development

An intra‐oral 3D scan (IOS1; TRIOS®, 3Shape, Copenhagen, Denmark) and clinical photographs were taken. CBCT scans were taken under the supervision of a specialist oral and maxillofacial radiologist utilizing the following protocol (Morita X800®, Morita Corporation): FOV 5.0 × 8.0 cm, 90Kv, 9 mA, 125 μm resolution for 18 s with a resultant radiation dose of approximately 150 μSv. The IOS and DICOM data were used to create a digital wax‐up outlining the desired implant restoration, implant size and position using a dental implant planning software (CoDiagnostix®, Dental Wings, Montreal Canada). This digital plan was then exported as an STL file and used to assist during the segmentation of the precise 3D anatomical model of the defect using specialized medical engineering software (Materialise Mimics version 23.0, Materialise, Technologielaan 153,001 Leuven Belgium).

3.2. Scaffold model

The anatomical model was converted into an STL file and refined using Materialise 3‐Matic Research 15 (Materialise NV, Leuven, Belgium). In this software, a volume was shaped to match the missing bone's contour, forming the scaffold's blueprint. The external boundary of this volume was then isolated and excised, defining the implant's geometry. Clinically designated fixation holes, each 0.7 mm in diameter, were integrated into the design. The implant's surface received a UV map with a standard value of 4. This was followed by the addition of a UV lattice pattern using a circular unit cell design. A consistent thickness of 0.8 mm was applied to this UV map (Figure 1d–f).

3.3. Scaffold fabrication

The 3D printing occurred inside a purpose‐built biosafety cabinet (LabGard® ES Energy Saver Class II) set to Australian Standard AS1807:2021. The scaffold was manufactured using the EnvisionTEC 3D‐Bioplotter® Developer Series printer and Medical‐grade PC08 PCL (viscosity 0.82 dL/g (Corbion NV, Netherlands)). The printing process involved using a 200 μm Tecdia Arqué needle for PCL at a temperature of 110°C, with a movement speed of 1 mm/s and a pressure of 400 kPa. The maltitol support structure was printed simultaneously (Figure 1g,h). The implants were plasma cleaned using a Harrick Plasma PDC‐002‐HP vacuum plasma cleaner in an environment consisting of oxygen (O2) and argon (Ar) gases. The flow rates were precisely controlled, with O2 delivered at 15 mL/min and Ar at 5 mL/min. The plasma cleaning process lasted for 4 min and was performed at a medium power setting of 38 W. After the plasma cleaning process, the scaffolds were heat sealed in gamma‐compatible chevron pouches (Sabre Medical Pty Ltd, New South Wales, Australia). The sealing process was executed with NITRASEAL at setting 5 for a duration of 9 s (Sirona Dental Systems GmbH, Bensheim, Germany; Figure 1j,i). The sealed implant was enclosed in a larger chevron pouch and sealed again with the same settings as the inner pouch. Sterilisation was performed at an irradiation dose of 18.4 kGy (Steritech, Queensland, Australia).

3.4. Clinical procedures

3.4.1. Surgical procedure—Staged ridge augmentation (T1)

Ridge augmentation was performed under general anaesthesia by an experienced clinician (JA; Figure 2). Systemic antibiotic therapy (500 mg Amoxycillin) and 0.2% Chlorhexidine mouth rinse began 24 h prior to surgery. Access to the region of interest (ROI) was through elevation of a full buccal mucoperiosteal flap. Multiple perforations of the cortical bone in the recipient site were performed. Autogenous bone was harvested using a bone scraper (Safescraper Twist, META, C.G.M Sp.A, Reggio Emilia, Italy) from the mandibular retro‐molar/ascending ramus region. The autogenous bone (AB) shavings were mixed with small particle deproteinized bovine bone mineral (particle diameter 0.25–1 mm; ABBM; Bio‐Oss®, Geistlich AG, Wolhusen, Switzerland) in a 1:1 ratio followed by the addition of prepared injectable platelet rich fibrin (iPRF). Up to 20 mL of whole blood was initially collected in two 10 mL uncoated vacuum tubes (Silfradent SRL, Santa Sofia, Italy) and centrifuged immediately for 13 min (2 min 2700 rpm/326 g, 4 min 2400 rpm/258 g, 4 min 2700 rpm/326 g and 3 min 3000 rpm/402 g; Medifuge, Silfradent SRL, Santa Sofia, Italy). The resulting supernatant (approx. 2 mL/tube) which represents liquid PRF, was aspirated then dispensed onto the bone graft mixture. This mixture was then loaded into the scaffold and carefully manoeuvred into final position and secured to the recipient site using three fixation screws (self‐drilling screws 1.5 × 5 mm; Medartis® Basel, Switzerland) ensuring immobilization (Figure 2b,c). The PCL scaffold was covered with a resorbable porcine collagen membrane (Bio‐Gide®, Geistlich AG, Wolhusen, Switzerland). A periosteal release was subsequently performed, and tension free closure achieved by using a non‐resorbable polypropylene monofilament suture (Prolene® 5/0 and 6/0 Dynek, Ethicon, Johnson & Johnson MedTech) to achieve primary closure (Figure 2d). A post‐operative dose of Bupivicaine was provided and a regimen of Amoxycillin 500 mg three times daily for 7 days was prescribed. A 0.2% Chlorhexidine mouth rinse was used twice daily for 7 days. NSAIDs analgesics (Paracetamol 500 mg, Ibuprofen 200 mg) were taken on as needed basis. Regular mechanical plaque control was recommended for regions beyond the surgical site.

FIGURE 2.

FIGURE 2

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Stages of scaffold‐guided bone regeneration (SGBR) in treating a horizontal maxillary bone defect. (a) Pre‐operative baseline. (b, c) Scaffold placement and fixation using titanium self‐drilling surgical screws combined with a mixture of PRF, ABBM and autologous bone. (d) Wound closure post GBR. Key: S = PCL scaffold, BG = autogenous/bovine bone mineral bone graft, Fx = Titanium Fixation Screws.

3.4.2. Follow up – SGBR‐staged ridge augmentation

The patient was reviewed clinically at 1, 2 and 8 weeks following surgery. Sutures were removed 14 days later. Intra‐oral digital scans of the site were taken at 14 days (IOS2) and 2 months (IOS3) after surgery. Further imaging (CBCT2 and IOS4) was carried out to finalize the restoratively driven digital plan and select implant dimensions 2–3 weeks prior to implant placement using implant planning software (CoDiagnostix®, Dental Wings, Montreal Canada). This information was transferred to the clinic via a surgical guide.

3.4.3. Volumetric assessment

Volumetric assessment was performed by using specialized medical engineering software (Materialise Mimics version 23.0 and Materialise 3‐Matic Research 15, Materialise, Technologielaan 153,001 Leuven Belgium). The initial defect volume was calculated using CBCT1 after segmentation of the precise 3D anatomical model of the defect. The ROI was defined as the region of absent bone beneath the scaffold (Figure 3g). To calculate the volume gain, segmentation of the anatomical model using CBCT2 was also carried out and then superimposed onto CBCT1 using a best‐fit algorithm at unchanged surfaces of teeth and other anatomical landmarks (Figure 3h). Alignment of these models was manually verified and adjusted to achieve ideal superimposition. The volumetric gain was identified within the ROI and measured. Triplicate measurements were carried out and reported as a mean volume to determine the absolute initial volumetric gain (mm3) and volume gain as a fraction of original defect (%) at 6 months after grafting.

FIGURE 3.

FIGURE 3

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Radiographical comparison of pre‐staged GBR CBCT and after 6 months of healing. (a and c) Pre‐op sagittal and coronal cross sections; (b and d) 6‐month post‐op sagittal and coronal cross sections; (e and f) 3D reconstruction of the CBCT images (pre‐ and 6 months post‐op); (g) Pre‐op defect volume; Ti, titanium fixation screw; (i) the pink volume represents the region beneath the scaffold absent of bone; (h) 6‐month volumetric gain; (ii) segmentation of the grey volume represents the difference between pre‐op and 6‐month CBCT via Boolean subtraction. Scale bar = 0.5 cm.

3.4.4. Surgical procedure—dental implant placement (T2)

Dental implant placement was successfully performed under local anaesthesia 6 months after ridge augmentation. Access to the alveolar ridge was via a full thickness mucoperiosteal flap. Osteotomy preparation was completed using a standard guided surgical technique. A bone sample was collected using a standard trephine bur with an internal/external diameter of 2.0/3.0 mm respectively. The trephine was directed in the exact 3D position as the dental implant osteotomy via the surgical guide. A single bone level dental implant (Straumann® Institut Straumann AG, Basel, Switzerland) with a micro‐roughened sandblasted and acid‐etched (SLA) surface was placed. A healing abutment was secured and mucoperiosteal flaps sutured using a non‐resorbable polypropylene monofilament suture (Prolene® 5/0 and 6/0 Dynek, Ethicon, Johnson & Johnson MedTech) to allow for a trans‐mucosal healing modality. A post‐operative regimen of Amoxycillin 500 mg three times daily for 7 days was prescribed. A 0.2% Chlorhexidine mouth rinse was used twice daily for 7 days. NSAIDs analgesics (Paracetamol 500 mg, Ibuprofen 200 mg) were taken on as needed basis. Regular mechanical plaque control was continued for regions beyond the surgical site.

3.4.5. Clinical follow up and evaluation—implant placement

The following parameters were recorded during implant placement:

  • Presence of residual alveolar bone defect—classified according to Benic & Hammerle, 2014 (Benic & Hammerle, 2014) and defect dimensions after flap elevation and prior to osteotomy preparation.

  • Implant dimensions (diameter, length) and primary stability achievement.

  • Need for use of a vertical releasing incision.

  • Need for additional grafting, type of biomaterial utilized and volume.

  • Need for periosteal releasing incision to achieve adequate flap closure.

Implant feasibility and restoration aesthetics:

Based on the restoratively driven implant plan the following aspects were evaluated:

  • Deviation between pre‐graft and post‐graft implant position.

  • Deviation from planned implant diameter.

The aesthetic outcome of the implant supported restoration was objectively measured using an aesthetic index (PES/WES score; Belser et al., 2009).

3.4.6. Post‐operative healing and morbidity

Post‐operative morbidity including oedema, haemorrhage, wound dehiscence, infection and altered sensation were assessed at 1, 2 and 8 weeks after ridge augmentation surgery. In addition, early wound healing was measured using an index that assesses signs of wound epithelialization, haemostasis and inflammation to provide an overall Early Wound Healing Score (EHS) ranging from 0 to 10 (Marini et al., 2018).

3.4.7. Patient‐reported outcome measures (PROMs)

The following post‐operative PROMs were recorded after both ridge augmentation and dental implant placement:

  • Average, maximum and present post‐operative pain was measured using a VAS for 14 days. This consisted of a 100‐mm line with clearly defined endpoints. One end of the line was labelled ‘no pain’ and the other end of the line was labelled ‘most intense pain imaginable’. A similar VAS was used to record average interference with daily activities. A score of <5 mm is indicative of no pain, 5–44 mm score indicates mild pain, 45–74 mm score indicates moderate pain and ≥75 mm indicates severe pain (Jensen et al., 2003).

  • The patient was asked to list the dose and time analgesics taken beyond the first 48 h and up to 14 days post‐operatively, and any additional analgesics beyond what was prescribed during the first 48 h post‐operatively.

  • In addition, at the 14 days review the following signs were recorded as either present or absent: wound dehiscence, wound infection (suppuration and oedema), extra‐oral bruising, oedema and other signs of morbidity including altered sensation.

3.4.8. Histological analysis

The bone sample was immersed in 4% paraformaldehyde pH 7.3 for 48 h at 4°C and then placed in PBS solution until sample preparation. The undecalcified sample was dehydrated in a graded series of ethanol solutions and then resin infiltrated (Methyl Methacrylate/Glycol Methacrylate, Technovit 7200, Morphisto, Germany). Once cured, the resin blocks were mounted on a plastic slide and ground using an EXAKT 400 CS micro‐grinding system. Thereafter, a glass slide was mounted to the block and a 150 μm section was cut using a diamond band saw as part of the EXAKT 300 cutting system (Exact Apparatebau, GmbH Norderstedt Germany) and polished down to a thickness of 20 μm using the using the EXAKT 400 CS micro grinding system. Samples were subjected to Haematoxylin and eosin (H&E; abcam 245,880) staining protocols according to standard procedures. Initially, to remove the resin layer, samples underwent two successive immersions in 100% acetone, each lasting 4 min. Subsequently, samples were rehydrated through a graded series of ethanol‐water solutions, culminating in pure water. Rehydration was followed by staining with Mayer's haematoxylin for 4 min, facilitating nuclei visualization. Post‐haematoxylin staining, samples were dehydrated in an ascending series of ethanol concentrations and then stained with Eosin for 10 min, highlighting cytoplasmic and extracellular matrix components. Finally, samples were mounted onto glass slides using a conventional mounting medium for microscopic examination.

4. RESULTS

4.1. Staged ridge augmentation—surgical outcomes and post‐operative follow up

The augmentation surgery proceeded as planned without significant incident. The personalized PCL was successfully fixed using three titanium fixation screws to the recipient site with an acceptable degree of accuracy of fit and structurally integrity. Minimal flexibility of the PCL scaffold was evident, but this did not prevent manipulation or fixation of the construct. (Figure 2b,c).

At 1‐week post‐augmentation, moderate extra‐oral swelling was noted with no signs of wound dehiscence or altered sensation. At total EHS of 5 was given as incisions were in contact but not yet merged (3) with absence of fibrin and visible inflammation signs still (0). At 3 weeks and at 9.5 weeks later, there was no visible oedema, absence of dehiscence and no altered sensation. Furthermore, a total EHS of 10 was given as incisions were merged (6) with absence of fibrin (2) and without signs of inflammation (2).

4.2. Volumetric assessment

The initial bone defect volume was determined to be 336.28 mm3. The mean post‐augmentation ridge volume was 364.69 ± 2.53 mm3, thus resulting in a volumetric fraction gain of 108.4% relative to the original defect (Figure 3).

4.3. Histological analysis

The histological examination of the bone core specimen revealed a mature healed site, with identifiable residual graft particles, the presence of new bone and no obvious inflammatory infiltrate (Figure 4). The specimen showed successful integration of new bone with the particulate graft across all defect zones (coronal, medial and apical; Figure 4i–iii). Bone bridging between the graft particles was evident, with continuous new bone formation observed encircling and interconnecting the particles. Bone of varying degrees of maturity was observed ranging from woven bone to mature bone with the emergence of haversian canals, and longitudinal and concentric lamellae (Figure 4iii). Bone remodelling cells were especially prominent at the borders of the particulate graft, and the presence of bone multicellular units (BMUs) was also apparent (Figure 4iii). The section was devoid of immune cells typically associated with chronic inflammation, such as lymphocytes and macrophages. Overall, the histological analysis was consistent with a well‐tolerated integration process, and an environment conducive for bone regeneration.

FIGURE 4.

FIGURE 4

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Histological analysis of the bone core utilizing haematoxylin and eosin (H&E) stain. a: Displays the overall morphology of the bone core subdivided into three zones by the white dashed line: (i) coronal, (ii) middle and (iii) apical. The white box indicates the region under high magnification in i–iii. NB: New bone, P: Particulate graft (ABMM), black arrows: Evidence of direct new bone formation resulting in bridging of bone substitute particles, yellow arrows: Emergence of bone multicellular units, blue arrows: Presence of multi‐nucleated giant cells.

4.4. Implant surgery outcomes

At implant placement, an intact alveolar ridge was noted with complete hard tissue fill of the original defect (Figure 5). Integration of the residual scaffold material to regenerated hard tissue was evident. Guided implant placement proceeded as per standard protocol with placement of a regular collar 4.1 × 12 mm bone level implant and achieved primary stability at 35Ncm−1. A small releasing incision was needed to remove one of the three fixation screws as its location would have interfered with osteotomy preparation. The remaining two fixation screws were left in‐situ. No periosteal release was required since no additional bone augmentation was needed. A trans‐mucosal healing modality was employed. The procedure took a total of 40:56 min/s.

FIGURE 5.

FIGURE 5

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Titanium Implant Placement Following SGBR. (a, b) Pre‐operative baseline. (c, d) Open flap prepared for implant placement. (e, f) Titanium implant insertion at the regenerated site. S = PCL scaffold and Im = implant.

4.5. Implant feasibility and restoration aesthetics

The implant was successfully restored by the referring clinician which included abutment connection as per manufacturer recommendations at 35Ncm−1 12 weeks after placement. When compared to the initial restoratively driven implant plan pre‐bone augmentation surgery, the post‐grafting planned implant position deviated overall by 2.4 degrees, 1.08 mm coronal neck of the implant and 1.24 mm at the apical tip (Figure 6). There were no changes to the implant dimensions initially planned (Figure 6). At the pre‐treatment initial presentation, the PES/WES score for the natural tooth was 4 and 2 respectively (Figure 7a,b). The PES/WES score at baseline assessment soon after delivery of the implant restoration was 7 and 9 respectively (Figure 7c,d).

FIGURE 6.

FIGURE 6

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(a) sagittal CBCT with super‐imposed outlines of the pre‐graft (red), post‐graft, and final implant position (blue). (b and c) Superimposed view of the implant position pre‐graft (red) and post‐graft (blue) illustrating extent of implant deviation.

FIGURE 7.

FIGURE 7

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Visual analysis of dental aesthetics pre‐tooth extraction (a, b) and post‐implant restoration (c, d; taken immediately post‐delivery of the crown). (a, b) Illustrates the pre‐treatment condition of the natural tooth at frontal and lateral views. (c, d) Illustration of the early post‐implant restoration condition at frontal and lateral views.

4.6. Patient‐reported outcome measures

The patient‐reported low average daily pain, low worse daily pain and low present pain during the first 48 h after both bone augmentation and implant surgery (Figure 8). This reduced to no pain from day 3 until the end of the 14‐day follow up period. The patient did not require any additional analgesics after the day of augmentation and implant surgery. Moderate interreference with daily activities was reported for the first 3 days post‐operative days reducing to mild interference thereafter (Figure 8d).

FIGURE 8.

FIGURE 8

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Patient‐reported outcome measures taken post SGBR treatment. (a) Average pain experienced in the last 24 h for 14 days. b: Worst pain experienced in the last 24 hrs for 14 days. (c) Present pain level for 14 days. d: Average interference to daily activities for 14 days.

5. DISCUSSION

This is the first report of the fabrication of an ‘in‐house’ designed and manufactured resorbable 3D‐printed, patient‐specific PCL scaffold using a quality management system compliant with the Australian regulatory requirements for clinical trials of a Class III implantable medical device. The scaffold was used to successfully regenerate alveolar bone that subsequently facilitated a functional dental implant supported restoration.

The presented approach represents a variation of the well‐established GBR concept which has been utilized for bone regeneration for several decades. Indeed, GBR using resorbable membranes supported by particulate bone grafts are clinically effective at regenerating smaller well horizontal contained defects (Chappuis et al., 2018; Christensen et al., 2003) when combined with fixation (Meloni et al., 2019). However, these membranes are not predictable for regenerating vertical or complex three‐dimensional defects due to their lack of form stability (McGinnis et al., 1998; Stavropoulos et al., 2004; Urban et al., 2019). Titanium reinforced PTFE membranes (Urban et al., 2014, 2015, 2021) or off‐the‐shelf titanium mesh overcome this limitation, but they require precise intra‐operative shaping and trimming to accommodate the specific defect characteristics. This can be difficult in complex 3D defects and is especially critical in the aesthetic zone where re‐creating the correct ridge configuration is paramount to a successful outcome. Furthermore, their removal during implant placement may require additional surgical time and elevation of larger mucoperiosteal flaps than would otherwise be needed for implant placement alone. Pre‐fabricated custom titanium mesh overcomes some of these disadvantages and has been shown to be effective for regenerating alveolar ridge defects (Chiapasco et al., 2021; Dellavia et al., 2021). These devices however still require second stage removal and are associated with a high incidence of post‐operative wound dehiscence (Chiapasco et al., 2021; Ciocca et al., 2018; Cucchi et al., 2020, 2021; Hartmann & Seiler, 2020; Lizio et al., 2022; Sagheb et al., 2017; Sumida et al., 2015). In this context space maintaining devices composed of resorbable materials such as PCL and magnesium are a promising alternative due to their biocompatibility, resorbable nature (Blaskovic et al., 2023; Hwang et al., 2023; Kacarevic et al., 2022; Rasperini et al., 2015; Vaquette et al., 2021, 2022) and dimensional accuracy (Bartnikowski et al., 2020). The use of a space‐creating and wound stabilizing resorbable polymer device, as demonstrated in this study, represents an evolution of the GTR concept, whereby the traditional membrane is replaced by a robust 3D scaffold, in a concept that is being termed scaffold guided bone regeneration (SGBR) (Ivanovski et al., 2023; Schulze et al., 2023).

Similar to studies using patient specific titanium scaffolds (Cucchi et al., 2021; Lizio et al., 2022), this report yielded a high fraction of the regenerated defect volume. In fact, a greater volume was regenerated when compared to the original alveolar bone contour. This can be attributed to the dimensional stability and high biocompatibility of the PCL scaffold, as well as the favourable defect parameters created by a type‐4 horizontal defect (Benic & Hammerle, 2014). The increased volume gain beyond the initial defect volume is likely due to designing the scaffold slightly beyond the defect outline, with the rationale of favouring minor over‐ rather than under‐contouring of the regenerated alveolar ridge.

PCL is a highly biocompatible and slow resorbing polymer (Bartnikowski et al., 2019). This is illustrated by the normal progression of wound healing, without any complications throughout the 6 months after augmentation surgery or after implant placement. The presence of PCL was noted at implant surgery, demonstrating excellent integration with the surrounding bone. In fact, the polymer was well integrated to both overlying mucoperiosteal flap and underlying hard tissue graft. Three stages of inter‐dependent and overlapping patterns of PCL degradation have been highlighted (Bartnikowski et al., 2019) including an initial decrease in molecular weight mostly through non‐enzymatic hydrolysis (Shih, 1995), secondary loss of mechanical properties leading to a final loss of mass throughout the scaffold. Once the molecular weight has decreased sufficiently (<10KDa) then intra‐cellular degradation completes the resorptive process (Pitt et al., 1981; Woodward et al., 1985). These degradation stages are influenced by a complex interplay of the local environment, polymer molecular weight and the morphology/thickness of the scaffold (Bartnikowski et al., 2019). Optimizing PCL degradation properties via changes in molecular weight and the use of composite materials is the focus of ongoing research, with the aim of achieving timely degradation yet ensuring dimensionally stable bone formation. Nevertheless, it is inevitable that PCL material will remain at the time of implant placement and restoration. Therefore, as part of our workflow, we designed the PCL scaffold after digitally determining the future implant position, to ensure that the mesh is designed without direct contact with the implant, especially in the vicinity of the transmucosal area. This can also be verified and amended at the time of surgery as the PCL material can be easily trimmed if necessary.

Seating discrepancies have been reported in studies on patient specific titanium scaffolds (Li et al., 2021; Lizio et al., 2022). These deviations may be the result of a number of factors including accuracy and resolution of image acquisition, software planning errors (e.g. segmentation), and surgical (e.g. operator skill, over‐packed scaffold). In this report, the PCL scaffold, which is inherently more flexible than highly rigid titanium structures, demonstrated favourable tolerance properties for accurate positioning, while also being sufficiently robust to allow screw fixation. Compared to titanium meshes, the higher flexibility and lower rigidity of the PCL mesh may be less precise but nevertheless is sufficient for accurate positioning (Bartnikowski et al., 2020), and indeed the flexibility allows for greater adaptation at the time of placement. Whilst we do not have data to assess the accuracy of the seating or dimensional accuracy of the scaffold in this case, the minimal deviation of the implant position relative to the planned position demonstrates an acceptable level of accuracy. The combined advantages of PCL resorption and incorporation of the future digital implant position into the 3D printing design allowed for limited flap elevation during implant placement. This is illustrated in this report by a relatively short implant placement surgery procedure, low VAS pain scores and no additional analgesics. These parameters may have been even more favourable if removal of one of the fixation screws was not needed. This clinical technique for bone regeneration was demonstrated to be a favourable staged bone augmentation treatment protocol for a single implant supported restoration in the aesthetic zone. An acceptable aesthetic outcome was achieved with a combined PES/WES = 16 (Jones & Martin, 2014; Tettamanti et al., 2016). The absence of a comparative control group and the favourable defect parameters (horizontal defect), somewhat limits the clinical relevance of the results in a wider context. Furthermore, while the results are promising, they are based on a single patient case, which may limit the generalizability of the findings, until a larger comparative trial is completed.

This case report demonstrates the safe and effective use of a 3D‐printed, patient‐specific PCL scaffold for alveolar bone regeneration of horizontal defects, facilitating successful dental implant placement. Further comparative trials with established clinical protocols and longer follow up are needed to comprehensively evaluate the outcomes and advantages. Further developments of this technology are also being presently considered such as using PCL composites, the use of resorbable screws (e.g. magnesium) and internal scaffold features. The scaffold achieved significant volumetric bone gain with excellent tissue integration and allowed ideal implant placement with minimal patient morbidity. This was achieved through a combination of digital pre‐planning, accurate manufacturing and quality control, in addition to careful surgical technique. These findings affirm the potential of 3D‐printed PCL scaffolds to enhance the predictability and efficacy of bone regeneration procedures, offering a promising avenue for personalized dental reconstruction and functional restoration, without second stage device removal.

AUTHOR CONTRIBUTIONS

Saso Ivanovski: Conceptualization, methodology, data curation, investigation, supervision, resources, project administration, writing—review and editing. Reuben Staples: Conceptualization, methodology, software, data curation, formal analysis, writing—original draft, writing—review and editing. Himanshu Arora: methodology, software, data curation, writing—review and editing. Cedryck Vaquette—methodology, data curation, formal analysis, writing—review and editing. Jamil Alayan—Conceptualization, methodology, data curation, investigation, formal analysis, project administration, writing—original draft, writing—review and editing.

CONFLICT OF INTEREST STATEMENT

The authors declare that there are no conflicts of interest regarding the publication of this paper. No financial or personal relationships have influenced the outcomes and interpretations of this research.

ACKNOWLEDGEMENTS

We acknowledge funding support from The University of Queensland, School of Dentistry. Open access publishing facilitated by The University of Queensland, as part of the Wiley ‐ The University of Queensland agreement via the Council of Australian University Librarians.

Ivanovski, S. , Staples, R. , Arora, H. , Vaquette, C. , & Alayan, J. (2024). Alveolar bone regeneration using a 3D‐printed patient‐specific resorbable scaffold for dental implant placement: A case report. Clinical Oral Implants Research, 35, 1655–1668. 10.1111/clr.14340

DATA AVAILABILITY STATEMENT

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

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