Complications Following Orthognathic Surgery in Patients with Cleft Lip and/or Palate: A single-centre retrospective analysis of 57 consecutive patients

Summary

Objectives:

The most prevalent craniofacial abnormality in infants is cleft lip and/or palate (CL/P). Orthognathic surgery is necessary for 25–60% of patients in order to enhance face aesthetics and masticatory function. Nevertheless, there is a lack of defined complication profiles in this particular population. Thus, this study aimed to describe the spectrum and frequency of complications following orthognathic surgery in CL/P patients at a tertiary care referral centre.

Methods:

This retrospective cohort study included consecutive CL/P patients who underwent orthognathic surgery at Al Nahda Hospital, Muscat, Oman, between 2008–2022. Variables analysed included demographics, procedure type, length of stay and predefined complications (intraoperative haemorrhage, transfusion, dental injury, wound dehiscence, relapse, temporomandibular joint [TMJ] disorder, repeat surgery and condylar resorption). Complications were graded using the Clavien–Dindo Classification (CDC) and 95% Wilson confidence intervals (CI) were calculated.

Results:

A total of 57 patients were included in this study. Nearly half of patients underwent Le Fort I osteotomy (45.6%), followed by bimaxillary (31.6%), Le Fort I + genioplasty (10.5%), trimaxillary (8.8%), BSSO (1.8%) and BSSO + genioplasty (1.8%). Overall, 19 patients developed complications, most of which were CDC Grade III. The most frequent complication was relapse (10.5%), followed by TMJ disorder (5.3%), repeat surgery (5.3%), dental injury (3.5%), intraoperative haemorrhage (3.5%), wound dehiscence (1.8%), transfusion (1.8%) and there were no cases of condylar resorption.

Conclusions:

Complications developed in one-third of patients who underwent orthognathic surgery; however, most were manageable. Relapses were the most frequent complication and there were no life-threatening complications (CDC Grade IV–V), demonstrating overall safety of the procedure in CL/P patients.

Advances in Knowledge

• The current study showed that relapses are the most frequent complication (~10%) from orthognathic surgery in patients with cleft lip and/or palate (CL/P).

• There was no mortality observed in the current study, which highlights the safety of the procedure.

• This study's findings inform perioperative counselling and quality-improvement benchmarks for CL/P orthognathic programmes.

Application to Patient Care

• Postoperative complications among orthognathic surgery patients is common, however compilations can be minimised by creating awareness among orthogenetic surgeons followed by management.

1. Introduction

Cleft lip and/or palate (CL/P) is the most common craniofacial anomaly, affecting approximately 1 in every 700 new-borns worldwide.¹ Despite early cleft care, most patients continue to develop maxillary hypoplasia and malocclusion.² Consequently, 25–60% of individuals with CL/P require orthognathic surgery to improve masticatory function and facial aesthetics, and achieve optimal occlusion.^1,3 However, the surgical procedure is associated with various intraoperative and postoperative complications.⁴

Intraoperative complications include bleeding, improper fracture and injuries to the inferior alveolar and lingual nerves. Postoperative complications include nerve injury, haemorrhage, hearing problem, relapse, condyle malposition, neuropathic pain, infection and delayed union or non-union. Other complications include oronasal fistula, tooth damage, snoring and sleep apnoea.^4,5 Currently, few studies have adopted standardised complication grading systems. The Clavien–Dindo classification (CDC) provides a structured and validated approach to grade complications based on the therapeutic intervention.⁶

Patients with CL/P present unique challenges compared with non-cleft patients. Extensive scaring from previous surgeries, altered vascularity and complex occlusal goals could influence the complication profile and surgical outcome. However, studies investigating complication profile following cleft orthognathic surgery are not well established. Quantifying these risks with contemporary data is essential for informed consent discussions and appropriate service planning. Therefore, this study aimed to quantify the type and severity of complications in CL/P patients who underwent orthognathic surgery at a single tertiary care centre in Muscat, Oman.

2. Methods

This retrospective study included consecutive CL/P patients (N = 57) who underwent orthognathic surgery at the National Maxillofacial Unit, Al Nahda Hospital, Muscat, Oman. Data were obtained from the institutional surgical database and electronic medical records. Patients with unilateral or bilateral CL/P (with or without alveolar involvement) who underwent any orthognathic procedure, including Le Fort I osteotomy, bilateral sagittal split osteotomy (BSSO), bimaxillary, trimaxillary and/or genioplasty were included. Patient data with incomplete records for the variables reported were excluded from the analysis. This study was performed in accordance with STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines.

All surgical procedures were performed by a team of experienced oral and maxillofacial surgeons and senior residents under the Oman Medical Speciality Board following established protocols considering cleft-specific anatomical variations. The procedures performed included Le Fort I (for correction of malocclusion and maxillomandibular deformities), bilateral sagittal split osteotomy (BSSO for mandibular advancement) and genioplasty (for realigning and reshaping chin).^7–9 Postoperative management and follow-ups were performed according to institutional standard protocol.

All patients were evaluated through a standardised cleft-orthognathic protocol before surgery. The assessment included a detailed clinical examination, occlusal analysis and radiographic evaluation using panoramic and cephalometric imaging. For complex cases, 3D cone beam computed tomography (CBCT) scans were obtained to assess skeletal asymmetry, nasal septum deviation and airway dimensions. Model surgery or virtual planning was performed in every case to simulate the planned skeletal movements and to fabricate intermediate and final occlusal splints. Preoperative orthodontic decompensation was completed to align the dental arches and eliminate dental compensations that could interfere with surgical correction. This stage is particularly important in cleft patients, where scarred tissues and altered growth patterns may obscure true skeletal discrepancies. Nutritional and haematologic optimisation, especially correction of anaemia, was ensured prior to admission.

All patients were reviewed by the multidisciplinary cleft team, including orthodontists, anaesthetists and speech specialists. They were counselled regarding the expected outcomes, possible relapse and the importance of postoperative physiotherapy and follow-up. A prophylactic regimen consisting of 0.12% chlorhexidine mouthwash and a single dose of intravenous antibiotic (cefuroxime 1.5 g) was administered at induction, following institutional infection-control policy.

The operational complications were as follows: (1) intraoperative haemorrhage (blood loss >500 mL recorded by the anaesthesia team via standard methods such as suction canister volume measurement and gravimetric assessment of surgical sponges); (2) blood transfusion (any administration of allogeneic packed red blood cells, whether intraoperatively or within the first 48 postoperative hours; this information was obtained from the anaesthesia charts and nursing records); (3) dental injury (a broad definition that encompasses the full range of iatrogenic dental damage was adopted. Injuries identified clinically [tooth fracture, luxation, avulsion, new-onset mobility noted at the time of surgery or at the first postoperative visit] as well as those detected radiographically [root transection or new periapical pathology on postoperative panoramic or periapical films attributable to the osteotomy line] were included); (4) wound dehiscence (any clinically visible separation of the surgical wound margins whether partial or complete, mucosal or gingival identified at any postoperative visit. This included both cases that healed spontaneously with local wound care and those that required secondary closure); (5) temporomandibular joint (TMJ) disorder (new-onset TMJ symptoms pain, clicking, crepitus, restricted mouth opening or joint locking appearing during the postoperative follow-up period in patients who had been asymptomatic before surgery); and (6) condylar resorption (progressive morphologic changes of the mandibular condyle [volume loss, flattening, cortical irregularity] on serial postoperative imaging [panoramic radiographs or CBCT], with or without clinical correlates such as progressive anterior open bite or mandibular retrusion).

Immediately after surgery, patients were monitored in the surgical high-dependency unit for airway stability, bleeding and occlusal accuracy. Intravenous antibiotics were continued for 24–48 hours and then shifted to oral form for 1 week. Dexamethasone was administered for the first 24 hours to minimise facial oedema and discomfort. Adequate hydration and early mobilisation were encouraged. Oral hygiene instructions were reinforced, and patients were advised to rinse with chlorhexidine twice daily for 14 days. Analgesia was provided using alternating paracetamol and non-steroidal anti-inflammatory drugs unless contraindicated.

Maxillomandibular fixation (MMF) was selectively applied for 7–14 days depending on the stability of the osteosynthesis. This was followed by guiding elastics to fine-tune occlusion. Patients were maintained on a soft or blended diet for 4–6 weeks to allow proper healing of osteotomy sites. Jaw physiotherapy and mouth-opening exercises were started soon after MMF release to prevent stiffness or trismus. Clinical reviews were scheduled at 1 week, 1 month, 3 months and 6 months post-surgery, with repeat radiographs to evaluate bony healing, occlusal stability and early signs of relapse or TMJ dysfunction. The structured follow-up protocol and close orthodontic supervision were key in minimising complications and maintaining skeletal stability. This approach aligns with recent recommendations from contemporary cleft and orthognathic outcome studies showing that multidisciplinary care, early mobilisation and rigid fixation protocols contribute significantly to reducing postoperative morbidity and improving long-term functional outcomes.

Extracted variables included age at surgery, sex (where available), length of stay, procedure type and the following predefined complications: intraoperative haemorrhage, blood transfusion, dental injury, wound dehiscence, temporomandibular joint (TMJ) disorder, condylar resorption, relapse and repeat surgery. All outcomes reflected complications documented within routine postoperative follow-up visit; however, the dataset did not include time-to-event information. Complications were systematically graded according to the Clavien-Dindo Classification system [Table 1].⁶

Table 1.

Clavien-Dindo Classification of surgical complications.⁶

Grade	Definition
I	Any deviation from the normal postoperative course not requiring pharmacological treatment or surgical, endoscopic, or radiological intervention. Permitted therapeutic regimens are: antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy.
II	Requiring pharmacological treatment with drugs other than those permitted for Grade I complications. Blood transfusions and total parenteral nutrition are also included.
IIIa	Requiring surgical, endoscopic, or radiological intervention under local anesthesia or conscious sedation.
IIIb	Requiring surgical, endoscopic, or radiological intervention under general anesthesia.
IVa	Life-threatening complication requiring intensive or intermediate care unit management; single organ dysfunction (including dialysis).
IVb	Life-threatening complication requiring intensive or intermediate care unit management; multiorgan dysfunction.
V	Death of a patient.

Relapse was evaluated using serial lateral cephalometric radiographs taken at 3 time points: preoperatively (T0), within the first postoperative week (T1) and at a minimum of 6 months postoperatively (T2). Changes at the following standard skeletal landmarks were measured: A-point, ANS, PNS and B-point using cranial base superimposition on the sella-nasion line. A binary outcome analysis was performed.

Continuous variables were summarised as mean ± standard deviation and median (range). Categorical variables were expressed as n (%). For each complication, Wilson 95% confidence intervals (CI) were calculated; for 0-event outcomes the upper bound of the CI was reported.¹⁰ As only aggregated counts were available, no multivariable modelling was undertaken. All the analyses were descriptive and intended to provide baseline rates for clinical benchmarking purposes.

3. Results

A total of 57 patients were included in this study. The mean age at the time of surgery was 22.1 ± 4.5 years, and the median length of hospital stay was 2.0 ± 1.0 days. Most patients with CL/P underwent Le Fort I osteotomy (45.6%) or bimaxillary surgery (31.6%) followed by Le Fort I + genioplasty (10.5%), trimaxillary (8.8%), BSSO (1.8%) and BSSO + genioplasty (1.8%) [Table 2].

Table 2.

Distribution of orthognathic surgeries performed on patients with cleft lip and/or palate (N = 57).

Type of procedure	n (%)
Le Fort I	26 (45.6)
Bimaxillary	18 (31.6)
Le Fort I + genioplasty	6 (10.5)
Trimaxillary	5 (8.8)
Bilateral sagittal split osteotomy	1 (1.8)
Bilateral sagittal split osteotomy + genioplasty	1 (1.8)
Genioplasty only	0 (0.0)

In terms of complications, one-third of the sample (n = 19) experienced complications, most were CDC Grade III (10 patients). The most frequent complication was relapse (10.5%, 95% CI: 4.9–21.1), followed by TMJ disorder (5.3%, 95% CI: 1.8–14.4), repeat surgery (5.3%, 95% CI: 1.8–14.4), dental injury (3.5%, 95% CI: 1.0–11.9), intraoperative haemorrhage (3.5%, 95% CI: 1.0–11.9), wound dehiscence (1.8%, 95% CI: 0.3–9.3) and transfusion (1.8%, 95% CI: 0.3–9.3); there were no cases of condylar resorption. There was 1 case (1.8%) of vascular necrosis of the maxilla [Table 3].

Table 3.

Complications of orthognathic surgeries performed on patients with cleft lip and/or palate.

Complication	n (%)	95% CI*	CDC Grade
Relapse	6 (10.5)	4.9–21.1	IIIa
Vascular necrosis of maxilla	1 (1.8)		IIIb
Repeat surgery	3 (5.3)	1.8–14.4	IIIb
Temporomandibular joint disorder	3 (5.3)	1.8–14.4	II
Dental injury	2 (3.5)	1.0–11.9	II
Intraoperative haemorrhage	2 (3.5)	1.0–11.9	II
Blood transfusion	1 (1.8)	0.3–9.3	II
Wound dehiscence	1 (1.8)	0.3–9.3	I
Condylar resorption	0 (0.0)	0.0–6.3	0

CI = confidence interval; CDC = Clavien–Dindo Classification

^*CIs were computed with the Wilson method; for 0-event outcomes the upper 95% bound is shown.

4. Discussion

Patients with CL/P present unique anatomical features that challenge surgical intervention and sometimes results in postoperative complications. In the current cohort, complications were reported in nearly one-third of the CL/P patients who underwent orthognathic surgery. Relapses (10.5%) were the most common complication, followed by TMJ disorder and repeat surgery (each 5.3%). Most complications were minor and were graded CDC Grade III (n = 10) requiring surgical intervention for resolution.

The relapse rate in the current study is lower that reported in other similar studies which describe rates as high as 25–50%.^11,12 Another study found relapse rates ranging from 4.6% at the mandibular positioning to 24.4% at the maxillary angle.¹³ These higher rates reflect the clinical reality that achieving and maintaining ideal occlusion in CL/P is challenging due to scarred tissues, prior surgeries, compromised maxillary growth, muscle pull, soft tissue tension, interference with the nasal septum and instability of bone fragments. Inchingolo et al. reported relapse rates exceeding 20–30% following mandibular setback and maxillary advancement procedures.¹⁴ The relatively low relapse rate (10.5%) and enhanced stability in this cohort can be attributed to the expertise of oral and maxillofacial surgeons and their adaptation to cleft-related anatomical variations. This percentage (10.5%) represents the patients (n = 6) with clinically documented skeletal relapse during postoperative follow-up and not an average displacement value. Systematic directional classification of relapse was not feasible within this retrospective dataset, a limitation that is acknowledged and is consistent with how relapse is reported in comparable retrospective complication surveys. All 6 patients were managed according to accepted post-orthognathic relapse protocols: 1 patient required revision surgery (CDC Grade IIIb), while the remaining 5 were managed non-surgically through orthodontic adjustment including elastic guidance, arch wire modification and occlusal splint therapy with satisfactory functional outcomes documented in all cases. A prospective study incorporating standardised directional cephalometric analysis at defined postoperative intervals is currently in preparation by the authors' group.

In the current study, 3 patients underwent repeat surgery, first patient underwent Le Fort I advancement and developed severe maxillary relapse (>6 mm) during the first six months of follow-up. Orthodontic measures were attempted but could not restore an acceptable occlusion. A revision Le Fort I osteotomy with repeat advancement was carried out approximately 8 months after the original surgery. The patient went on to achieve stable occlusion and a good functional result. In the second case, following bimaxillary surgery, the patient developed persistent discomfort and soft tissue irritation at a titanium miniplate site along the Le Fort I osteotomy line. Conservative management (observation, soft diet, anti-inflammatory medication) did not resolve the symptoms. The hardware was removed electively at 12 months postoperatively. The patient recovered without further issues. The third case had localised avascular necrosis of the premaxillary segment following Le Fort I osteotomy in a bilateral CL/P patient. Surgical debridement was required at approximately 3 weeks, with further constructive management over the subsequent months.

The absence of condylar resorption in the current cohort was a reassuring finding. Nevertheless, the upper 95% CI (approximately 6%) shows that rare events remain plausible in similar-sized cohorts. In contrast, other studies reported condylar resorption in 1 in 10 patients who underwent orthognathic surgery. Franco et al., reported that 20% of patients who underwent mandibular advancement experienced follow-up changes in the condylar position and adaptive bone remodelling.¹⁵ Verhelst et al. reported an incidence of 9.5% in their large cohort who received either only a BSSO or a BSSO + Le Fort I osteotomy.¹⁶ Similarly, Nino-Sandoval et al. documented a pooled incidence of 12.3% in their recent systematic review on postoperative condylar resorption.¹⁷ The probable mechanism is that after surgical-orthodontic treatment, condyle might relocate postero-superiorly and later move to a more concentric position over time.¹⁸

TMJ-related symptoms and the need for repeat surgery in the current study (5.3% each) underscores the importance of preoperative occlusal planning, rigid fixation and postoperative orthodontic control. Sahu et al. reported that TMJ symptoms improved in patients with pre-existing dentofacial deformities. However, a few patients who were asymptomatic before surgery developed new TMJ symptoms, and in some cases, pre-existing symptoms worsened.¹⁹ The reasons for symptom improvement might be due to (1) changes in the condyle-disc relationship, which relieves joint stress in patients with pre-existing internal derangements; (2) resolution of muscle disorders from improved masticatory ability and corrected occlusal interference; and (3) decreased bruxism or clenching.²⁰ The low rates of wound dehiscence (1.8%), vascular necrosis (1.8%) and transfusion requirements (1.8%) further support the safety of current perioperative management. The vascular necrosis patient was a young adult with bilateral cleft lip and palate who had undergone multiple prior procedures (primary lip and palate repair, secondary alveolar bone grafting) before presenting for Le Fort I osteotomy with advancement. At the 1-week follow-up visit, the surgical team noted progressive grayish discoloration and mucosal breakdown overlying the premaxillary/anterior maxillary segment. There was localised soft tissue swelling and a foul odour. Importantly, this was confined to the premaxillary region the posterior maxillary segments and palatal tissues appeared viable and well-perfused. The wound healed over 8–12 weeks. The overall Le Fort I advancement maintained the skeletal correction and occlusion remained stable. At last follow-up, the patient had acceptable facial aesthetics and functional occlusion.

This study was subject to several limitations. This was a single-centre study with modest sample size in which low counts may limit precision for rare events. The retrospective nature of the study limited data extraction from available existing medical records. Consequently, it was not possible to compare outcomes between cleft and non-cleft control groups, which may influence the generalisability of reported complication rates. Furthermore, the aggregated data precluded patient-level risk modelling (e.g., by procedure, segmentation, cleft type, follow-up duration). The follow-up period and definitions were based on clinical documentation and may vary across centres. To address these constraints, multicentre, prospective studies with a large sample size stratifying patients by age, sex, cleft subtype, surgical approach, fixation method, operative time and months of follow-up are required. Such studies will help in identifying independent risk factors and procedure-stratified complication rates.

Overall, the current study's results demonstrate that most complications were minor, uncommon and manageable without long-term consequences. Moreover, the absence of Grade IV and V complications further confirms the safety of orthognathic surgery. These data, focusing on a homogeneous CL/P orthognathic cohort, can serve as benchmarks for complication rates, perioperative counselling and quality improvement in similar tertiary care centres. Furthermore, the transparent reporting of absolute risks with appropriate CIs, including 0-event outcomes, can guide clinicians to use the proportions for accurate patient counselling (e.g., “advising a relapse risk of ~10%, typically within the first year”).

5. Conclusion

One-third of the patients who had orthognathic surgery for CL/P experienced complications, but the majority were mild and controllable. The most common consequence was relapses. The treatment can generally be considered safe in this patient population as there were no life-threatening consequences (CDC Grade IV–V). These data can inform perioperative counselling and quality-improvement benchmarks for CL/P orthognathic programmes.

Authors' Contribution

Ahmed Shawqi Alqattan: Writing - Original Draft, Writing - Review & Editing. Ahmed Al Hashmi: Conceptualization. Said Al Rashdi: Data Curation. Mohammed Al Nabhani: Methodology

Acknowledgement

We thank the multidisciplinary cleft and orthognathic teams (surgeons, senior residents under Oman Medical Speciality Board, orthodontics, anaesthesia, nursing and dietician) for their contributions to patient care and data collection.

Ethics Statement

Ethical approval for this study was obtained from the Centre of Studies and Research of the Ministry of Health (MOH/DGKH/REC/22/8/25631) A waiver for individual patient consent granted due to the retrospective and deidentified design of this study.

Conflict of Interest

The authors declare no conflicts of interest.

Funding

No funding was received for this study.

Data Availability

De-identified data and analysis scripts are available from the corresponding author on reasonable request, in line with institutional policy.