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Objective: Cleft lip and palate is the most common craniofacial birth anomaly and requires surgery in the first year of life. However, craniofacial surgery training opportunities are limited. The aim of this study was to present and evaluate an open-source cleft lip and palate hybrid (casting and three-dimensional (3D) printing) simulation model which can be replicated at low cost to facilitate the teaching and training of cleft surgery anatomy and techniques. Design: The soft tissue component of the cleft surgery training model was casted using a 3D printed 5-component mold and silicone. The bony structure was designed to simulate the facial anatomy and to hold the silicone soft tissue. Setting: Two groups, one group of trainees and one group of expert surgeons, at University Hospital Basel in Switzerland and Pontifical Catholic University of Chile in Santiago, Chile, tested the cleft lip and palate simulation model. Participants completed a Likert-based face and content validity questionnaire to assess the realism of the model and its usefulness in surgical training. Results: More than 70 % of the participants agreed that the model accurately simulated human tissues found in patients with unilateral cleft lip and palate. Over 60 % of the participants also agreed that the model realistically replicated surgical procedures. In addition, 80-90 % of the participants found the model to be a useful and appropriate tool for teaching the anatomy and surgical techniques involved in performing unilateral cleft lip and palate repair. Conclusion: This open-source protocol provides a cost-effective solution for surgeons to introduce the cleft morphology and surgical techniques to trainees on a regular basis. It addresses the current financial barrier that limits access to commercially available models during the early stages of surgeon training prior to specialization in the field.

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BACKGROUND: Presurgical plate therapy has been widely accepted as a treatment prior to palatal cleft closure. The effects of passive presurgical plate therapy on cleft morphology prior to single-stage unilateral cleft lip and palate (UCLP) repair were quantified. PATIENTS AND METHODS: We compared the dimensions of cleft width and cleft area (true cleft and palatal cleft) measured preoperatively at 2 European cleft centers. Center A performed single-stage UCLP repair in 8-month-old infants without any presurgical orthopedic treatment. Center B initiated passive presurgical plate therapy immediately after the birth of the neonates, followed by single-stage UCLP repair at 8 months of age. RESULTS: We included 28 patients with complete UCLP from Center A and 12 patients from Center B. The average anterior width of the true cleft before surgery was significantly smaller in infants at Center B than that in Center A (p = 0.001) with 95% confidence interval of (1.8, 5.7) mm, but the average posterior width was similar in the 2 groups. The mean presurgical true cleft area amounted to 106.8 mm2 (SD = 42.4 mm2) at Center A and 71.9 mm2 (SD = 32.2 mm2) at Center B, with a confidence interval for the difference being (9.8, 60.1) mm2. This corresponded to a 32.7% reduction of the true cleft area when passive presurgical plate therapy was used for the first 8 months of the infants' life. CONCLUSION: Passive presurgical plate therapy in UCLP significantly reduced the cleft area. Implications for the subsequent surgical outcome might depend on the surgical technique used.

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Introduction: Bony reconstruction of the alveolar process and its adjacent platform largely represents the final step in surgical achievement of functionality and aesthetics in cleft patients. Throughout the years, the success of this procedure has been investigated. The aim of this study was to assess the success rate of autogenous mid-secondary alveolar bone grafting in this setting. Methods and Material: A retrospective cohort study was performed. All cleft patients receiving secondary alveolar bone grafts between 1990 and 2020 were reviewed. Criteria for assessing success were long-term preservation of alveolar bone stock, ability of spontaneous or orthodontic-guided eruption and periodontal health of permanent lateral incisors and canine teeth, absence of exposed root structures of neighbouring teeth, absence of fistula and successful placement of implants. Failure of alveolar bone grafts was indicated by radiographically demonstrable total or near-total graft loss requiring reintervention. Results: A number of 124 patients were included and grouped as those primarily operated following our (two-staged palatoplasty) protocol and those receiving cheilorhinoplasty and palatoplasty (one-staged) at other centres. Given the limited cohort size, no complex statistical analysis was performed. In the first group of 64 patients 12 experienced complications (Veau III, eight/36; Veau IV, four/18). In the second group of 60 patients, 12 experienced complications (Veau III, six/37; Veau IV, six/17). Discussion: Our surgical protocol using anterior iliac bone grafts for secondary alveolar reconstruction achieved good results, comparing favourably with previous literature.

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BACKGROUND: Primary alveolar bone grafting inhibits craniofacial growth. However, its effect on craniofacial growth in one-stage cleft lip and palate protocols is unknown. This study investigated whether primary alveolar bone grafting performed during one-stage unilateral cleft lip and palate repair negatively affects growth up to 6-11 years old. METHODS: The craniofacial growth, dental arch relationship and palatal morphology at 6-11 years old in children with unilateral cleft lip and palate were compared retrospectively. Two cohorts after a one-stage protocol without (Group A) and with (Group B) primary bone grafting at the same center were compared. Further, cephalometric measurements for growth were compared with an external cohort of a one-stage protocol and a heathy control. RESULTS: Group A comprised 16 patients assessed at 6.8 years (SD 0.83), and Group B comprised 15 patients assessed at 9 years (SD 2.0). Cephalometric measurements indicated similar sagittal maxillary growth deficits and a significant deviation in maxillary inclination in both groups compared to the healthy group. Moderate to severe changes in palatal morphology were observed in 70% of the members in both groups. CONCLUSION: Omitting primary alveolar bone grafting under the one-stage protocol with two-flap palatoplasty studied did not improve growth at 6-11 years. The results implicate two-flap palatoplasty with secondary healing as having greater adverse effects on growth than primary alveolar bone grafting. Dental and palatal morphology was considerably compromised regardless of primary alveolar bone grafting.

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BACKGROUND: Enabling intelligible speech plays an important role in achieving social inclusion and a good quality of life of cleft patients. A crude measure of primary palatal repair quality is the incidence of operations to correct velopharyngeal insufficiency (VPI) after speech-language therapy has proven inadequate. This study assessed the necessity for surgery to correct velopharyngeal insufficiency following our standardized two-staged protocol, compared the results with the literature, and identified factors that may influence velopharyngeal competence. METHODS: A review of the literature was performed. The outcome measure in our series was the necessity for a secondary procedure to correct velopharyngeal insufficiency. The results of literature review were compared with the results of our case series, which we treated using a standardized protocol. RESULTS: In our retrospective study, 5 patients (2.5%) required secondary pharyngoplasty. In literature, the frequency of surgery to correct velopharyngeal insufficiency after one- and two-stage protocols were 13.6% and 24.5%, respectively. No statistical difference was found between bilateral and unilateral clefts. The frequencies of velopharyngeal surgery were 7.2% after Furlow palatoplasty, 17.5% after a 2-flap palatoplasty, 18.6% after a Wardill-Killner palatoplasty, and 35.6% after a Von Langenbeck palatoplasty. CONCLUSION: The literature reported that one-stage palatoplasty is correlated with a lower incidence of secondary pharyngeal surgery. Our standardized two-stage protocol proved successful in avoiding secondary velopharyngeal surgery but due to the reduced number of patients included in our study, more research is needed.

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OBJECTIVE: This study assessed the rate of maxillary osteotomies after cleft palate surgery following a standardized two-stage palatoplasty protocol. In order to improve our treatment strategy, the results were compared with the data extracted from the literature by means of a systematic review. DESIGN: Retrospective cohort study. PATIENTS: Non-syndromic cleft lip, alveolus, and palate patients with complete records who underwent primary cleft palate surgery. INTERVENTION: The incidence of midface hypoplasia after primary cleft surgery that required surgical intervention was retrospectively evaluated. RESULTS: Of the final 51 patients included in our retrospective analysis, two required a maxillary repositioning osteotomy. The frequency was lower than reported in the literature. In the literature, there was no difference between patients treated according to a one-stage protocol (21%) and patients treated according to a two-stage protocol (20.8%), but a higher incidence of pharyngeal surgery was noted in the two-stage closure group. Only the cleft type, timing of hard palate closure, and orthodontic treatment proved to influence the need for maxillary osteotomy. CONCLUSION: Our protocol shows promising results and needs more validation.

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OBJECTIVE: The aims of the study were to assess the postoperative oronasal fistula rate after 1-stage and 2-stage cleft palate repair and identify risk factors associated with its development. DESIGN: Systematic review. SETTING: Various primary cleft and craniofacial centers in the world. PATIENTS, PARTICIPANTS: Syndromic and nonsyndromic cleft lip, alveolus, and palate patients who had undergone primary cleft palate surgery. INTERVENTION: Assessment of oronasal fistula frequency and correlation with staging, timing, and technique of repair, gender, and Veau type. The results obtained in this systematic review were compared with those in previous reports. OUTCOME: The main outcome is represented by the occurrence of the oronasal fistula after 1-stage versus 2-stage palatoplasty. RESULTS: The mean fistula percentage was 9.94%. In the Veau I, II, III, and IV groups, the respective fistula rates were 2%, 7.3%, 8.3%, and 12.5%. Oronasal fistula locations based on the Pittsburgh Fistula Classification System were soft palate (type II), 16.2%; soft palate-hard palate junction (type III), 29.3%; and hard palate (type IV), 37.3%. There were no statistically significant differences between 1-stage and 2-stage palatoplasty, syndromic and nonsyndromic, or male and female patients. Primary palatoplasty timing was not a significant predictor. CONCLUSION: Some disparities arose when comparing studies, mainly regarding location and types of clefting prone to oronasal fistulation. Interestingly, the fistula rate does not differ between 1- and 2-stage closure, and timing of the repair does not play a role.

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PURPOSE: This study served to evaluate a two-stage concept in cleft palate repair, including key use of a triangular hinge ("flip-over") flap, in order to prevent palatal fistulae. It uses data from a prospective registry established in 1991. MATERIALS AND METHODS: The concept entails Furlow soft palate repair (at 1 year of age) and hard palate closure (at 4 years) by a three-pronged approach [paring of the edges with or without postero-lateral relaxing incisions, peninsula (Veau) flap(s)], plus a triangular hinge flap. The latter is elevated from the oral layer of the already-repaired soft palate, stays based anteriorly, and is flipped over to close the posterior nasal layer defect. The case series is compared with data from the literature. RESULTS: The palatal fistula rate for Veau II to IV types (two-stage surgeries) was 4.3%. The overall fistula rate in the cleft population (Veau I-IV) was 2.9%. Meta-analyses describe 4.9 and 8.6% on average. There was no difference between sample A in which the flip-over flaps were used only when modified Veau flaps were indicated (until 2006) and sample B in which it was used regardless of the technique of hard palate closure applied (2006-2018). The fistula rate decreased to zero after 2010, which may reflect also an influence of other factors such as the interpositioning of a collagen membrane and also of improved surgical judgment. CONCLUSIONS: Using a flip-over flap in two-stage cleft palate repair may contribute to prevent fistula formation at the hard/soft palate junction. LEVEL OF EVIDENCE: III.

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