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Presurgical infant orthopedics (PSIO) is the first step in the treatment of cleft lip and palate (CLP) and is designed to approximate the cleft segments as effectively as possible before surgical reconstruction of the lip and palate. The biomechanical efficacy of different PSIO approaches in transferring molding forces to the CLP is unknown. This study aimed to define the biomechanical principles of competing PSIO techniques in a real cleft finite element (FE) model. Active intraoral (Latham), passive alveolar molding (PAM), and extraoral (DynaCleft) molding forces were virtually applied to a real cleft FE model. In the cleft region, PAM (P < 0.001) and Latham (P < 0.05) exerted significantly less stress than DynaCleft. Intraoral molding forces acted primarily at the site of the force initiation without being accompanied by high loads in the midface. PAM showed a tendency toward a better flow behavior of the molding forces than Latham. Extraoral molding transferred high stresses to the cleft, alveolar ridge, and midface. Intraoral passive molding was ultimately characterized by the highest biomechanical efficacy and showed the most favorable load distribution of all of the PSIO approaches considered in this study. Future research is needed to validate the findings against clinical data.

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OBJECTIVE: Development and evaluation of a mobile application for remote monitoring and guidance of pediatric patients diagnosed with cleft lip and/or palate (CL ± P) and their caregivers. DESIGN: This is a pilot cross-sectional, applied, and quantitative study. SETTING: The study was conducted in two tertiary care treatment centers in Brazil. PARTICIPANTS: The participants included 20 caregivers and infants undergoing treatment with nasoalveolar molding (NAM) for CL ± P. INTERVENTIONS: The intervention involved using the TeleCleft mobile application for remote monitoring and guidance of caregivers and infants during NAM treatment. MAIN OUTCOME MEASURE(S): The main outcome measures included usability and satisfaction of users with the TeleCleft application. RESULTS: The results showed high usability and satisfaction ratings among users of the TeleCleft application. Most participants found remote monitoring to be effective and expressed positive opinions about its convenience and usefulness. CONCLUSION: TeleCleft could be a viable tool for remote monitoring and guidance, reducing the need for patients and caregivers to travel to treatment centers, which could potentially alleviate the burden of care faced by families during the journey of CL ± P treatment.

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BACKGROUND: The introduction of presurgical nasoalveolar molding represented a significant departure from traditional molding methods. Developed by Grayson and colleagues in 1993, this technique combines an intraoral molding device with a nasal molding stent. This study aimed to compare the Grayson nasoalveolar molding appliance versus DynaCleft appliance as two methods of presurgical nasoalveolar molding. METHODS: A single-blinded, randomized, parallel-arm clinical trial was conducted. Sixteen infants with complete unilateral cleft lip and palate were enrolled and divided into two groups of eight. Group 1 was treated with a modified Grayson nasoalveolar molding appliance that included a nasal stent, while group 2 was treated with DynaCleft elastic adhesive tape and an external nasal elevator. Standardized digital photographs of each infant were taken at baseline and post-treatment using a professional camera. Nine extraoral anthropometric measurements were obtained from each image using image measurement software. RESULTS: The modified Grayson nasoalveolar appliance demonstrated a more significant improvement compared to DynaCleft in terms of alar length projection (on both sides), columella angle, and nasal tip projection. Symmetry ratios also showed enhancement, with significant improvements observed in nasal width, nasal basal width, and alar length projection (p< 0.05). CONCLUSION: Both the modified Grayson nasoalveolar appliance and DynaCleft appear to be effective presurgical infant orthopedics treatment options, demonstrating improvements in nasolabial aesthetics. The modified Grayson appliance, equipped with a nasal stent, improved nasal symmetry more effectively than DynaCleft, resulting in a straighter columella and a more medially positioned nasal tip.

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Pre-nasoalveolar molding (PNAM) was developed to reduce the severity of the initial cleft alveolar and nasal deformity. The nasoalveolar moulding appliance (NAM) consists of an intraoral moulding plate with nasal stents to mould the alveolar ridge and nasal cartilage concurrently. Use of the NAM technique also reduces surgical columella reconstruction and the resultant scar tissue in bilateral cleft lip and palate. The nasoalveolar moulding technique has been shown to significantly improve the surgical outcome of the primary repair in cleft lip and palate patients compared to other techniques of presurgical orthopaedics. But the adaptability of nasal stent with support from NAM plate is cumbersome for many cleft patients due to its bulkiness, interfere with feeding and difficult for parents to manage at home. The Modified Indigenous Nasal Elevator (MINE) is a novel innovation for nasal correction for cleft lip and palate patients. This innovative design, non-invasive, precision, fewer visits, cost effective and adaptability make it a valuable tool to help surgeons to achieve optimal correction in lip repair surgeries in cleft lip & palate patients. MINE's innovative design allows for customization based on the patient's specific nasal anatomy. This adaptable feature ensures optimal fit and function for each patient, maximizing the surgical outcomes.

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AIM: Presurgical Nasoalveolar molding (PNAM) is a technique used for cleft lip and palate patients prior to cheiloplasty. However, concerns exist regarding its negative impact on maxillary arch growth.This study aimed to assess the effect of selective trimming in NAM on maxillary arch growth in patients with unilateral cleft lip palate. METHODOLOGY: The retrospective observational study analyzed the study casts of 30 patients before and after undergoing nasoalveolar molding treatment. Study casts which were repositories of the institute were analyzed and segregated as Group A: NAM given with selective trimming of the appliance, and Group B: NAM without selective trimming of the appliance. Pre and post-treatment casts were assessed digitally at L-L' (Intercleft segment width), C-C' (Intercanine width), T-T' (Alveolar arch width), L-TT' (Alveolar arch length from major cleft segment), and L'-TT' (Alveolar arch length from minor cleft segment) RESULTS: A notable significant difference between Group A's and B's mean Alveolar arch width and Intercleft segment width was seen. Whereas parameters such as intercanine width, and alveolar arch length as functions from major and minor segments showed no significant variance. CONCLUSION: Although NAM has been known to affect the growth of the maxillary arch, this study proposes that techniques such as selective trimming can help counteract this drawback.

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OBJECTIVE: This study aimed to determine the efficacy of gingivoperiosteoplasty (GPP) in preventing alveolar bone grafting (ABG) among children with cleft lip and palate (CLP). DESIGN/SETTING: Retrospective university hospital single center study. PATIENTS: Children with CLP treated with GPP from 2000-2015 were included. Those under eight years of age, without definitive conclusions regarding need for ABG or with incomplete data were excluded. INTERVENTIONS: Included patients were analyzed for demographics, cleft type, age at GPP, associated cleft surgery, use of nasoalveolar molding (NAM), indication for ABG, operating surgeon and presence of residual alveolar fistula. T-tests and Fisher's exact tests were utilized for statistical analysis. MAIN OUTCOME MEASURE: The need for ABG. RESULTS: Of the 1682 children identified with CLP, 64 underwent GPP and met inclusion criteria. 78% of patients with CLP who underwent GPP were recommended for ABG. Those who received GPP at a younger age (P = .004) and at the time of initial cleft lip repair (P = .022) were less likely to be recommended for ABG. Patients with complete CLP were more likely to be recommended for ABG than patients with cleft lip and alveolus only (P = .015). The operating surgeon impacted the likelihood of ABG (P = .004). Patient gender, race, ethnicity, laterality, and NAM were not significantly associated with recommendation for ABG. CONCLUSION: GPP does not preclude the need for ABG. Therefore, the success of ABG after GPP and maxillary growth restriction should be analyzed further to determine if GPP is a worthwhile adjunct to ABG in cleft care.

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OBJECTIVES: To three-dimensionally assess differences in craniomaxillofacial skeletal development in patients with operated unilateral cleft lip and palate (UCLP) treated with/without presurgical nasoalveolar molding (PNAM) with a mean age of 5 years. MATERIALS AND METHODS: Cone-beam CT radiographs of 30 patients with UCLP who had undergone PNAM and 34 patients with UCLP who did not receive PNAM were analyzed. The data were stored in DICOM file format and were imported into the Dolphin Imaging program for 3D image reconstruction and landmark identification. 33 landmarks, 17 linear and three angular variables representing craniofacial morphology were analyzed and compared by using the Mann-Whitney U tests. RESULTS: The vast majority of linear variables and 3D coordinates of landmark points reflecting craniofacial skeletal symmetry were not significantly different between the two groups. In terms of craniofacial skeletal development, the PNAM group had a significantly smaller anterior nasal spine offset in the midsagittal plane and a greater maxillary length compared to the non-PNAM group. CONCLUSIONS: Evaluations performed in early childhood showed that treatment with/without PNAM in the neonatal period was not a major factor influencing craniomaxillofacial hard tissue development in patients with UCLP; moreover, PNAM treatment showed significant correction of skeletal deviation at the base of the nose. CLINICAL RELEVANCE: Follow-up in early childhood has shown that PNAM treatment administered during the neonatal stage does not impede maxillary development and has benefits in correcting nasal floor deviation. It is a viable option for improving nasal deformity in children with unilateral cleft lip and palate.

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OBJECTIVE: To conduct a systematic review of the data in peer-reviewed medical literature and evaluate the effectiveness of lip taping as a pre-surgical naso-alveolar molding (NAM) technique in infants with cleft lip and/or palate. DESIGN: An electronic search of various databases for relevant studies, regardless of date, from inception to June 2023 was carried out and evaluated. After completing the electronic search and applying our inclusion/exclusion criteria, 6 studies-2 randomized control trials, 2 non-randomized studies, and 2 case series-were included. Data extraction of relevant articles was done independently by 2 authors. Quality assessment was done using the JBI prevalence critical appraisal tool and certainty of evidence was carried out by GRADE approach. MAIN OUTCOME MEASURES: Nasolabial Aesthetics, Dentoalveolar Relationship. RESULTS: A total of six studies were included in the current review. Meta-analysis was carried out, and forest plots were obtained for a single mean from the lip-taping group. 3 studies had a low risk of bias, while 3 studies displayed a serious risk of bias. Significant improvement in various outcome measures was noted with lip taping when compared with the control group although the certainty of evidence was very low. CONCLUSION: When compared to no therapy, lip taping appears to ameliorate dentoalveolar measurements and nasolabial aesthetics. To increase our knowledge of lip taping, more research will be needed in the future, as there are not many studies to prove lip taping is better than other treatment approaches.

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OBJECTIVE: Evaluate facial changes after Presurgical Naso-Alveolar Molding (PNAM) in unilateral cleft lip and palate (UCLP) patients treated with Modified Grayson Technique and AlignerNAM (with DynaCleft nasal elevator) using a 3D facial scan. DESIGN: Randomised clinical trial. SETTING: Institutional study. Participants: 20 UCLP patients allocated to two groups (10 patients each). INTERVENTIONS: Group A patients underwent PNAM with Modified Grayson Technique and Group B patients underwent AlignerNAM (with DynaCleft nasal elevator). Their 3D facial scans were obtained by using an iOSbased application (Bellus3D FaceApp) mounted on a novel frame. These .stl files were analysed using 3D software (GOM INSPECT) at three-time intervals; before intervention (T0), after intervention (T1) and one month after lip repair surgery (T2). MAIN OUTCOME MEASURE(S): Changes in facial and nasolabial morphology. RESULTS: Both techniques brought significant improvement in the columellar length, nasal tip projection, columella angle, nasal tip angle and a significant reduction in cleft width. At T1, a statistically significant difference in angular and linear measurements was present in both groups. At T2, no statistically significant difference in linear parameters was observed between the two groups except for the outer lateral height of the non-cleft side, basal lateral height of the non-cleft side, and philtrum width. Similar pattern was observed in angular measurements with no statistically significant difference between the two groups except in nasolabial angle, anterior nasal base triangle III, and anterior nasal root triangle. CONCLUSIONS: Aligner NAM and Modified Grayson technique are equally effective PNAM methods with similar clinical results in nasolabial morphology after lip repair surgery.

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Aim This study aimed to determine and compare the cytotoxicity of light-cured composite resin (Enlight light cure composite (Ormco, Glendora, California, USA)), light-cured acrylic resin (Orthocryl LC (Dentaurum, Ispringen, Germany)), and the self-cure acrylic (DPI RR cold cure acrylic (Dental Products of India, Bombay Burmah Trading Corporation Ltd., Mumbai, India)) material and to determine which component is best to be used for the purpose of nasal stent fabrication in the nasoalveolar molding (NAM) technique for cleft therapy. Methods Circular discs made from Enlight light cure composite, Orthocryl LC, and self-cure acrylic were submerged for 24 hours in gingival fibroblast media (three discs of each material) and control medium (three discs of each material) that were both contained in plates. After analyzing the optical densities of the plates, the cytotoxicity of the products was assessed by measuring cell viability using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay. The compiled data was analyzed using IBM SPSS Statistics for Windows, V. 23.0 (IBM Corp., Armonk, NY). The normality of the data was evaluated using the Shapiro-Wilk test. One-way analysis of variance (ANOVA) and pairwise comparison made with Tukey's honestly significant difference (HSD) post hoc test with a significance level (p) of 0.05 were considered. Results The percentage of cell viability was between 80% and 150%. A significant mean difference was noted in the cell viability between the three groups (p=0.009). High mean cell viability was seen in Orthocryl LC. However, there was no significant mean difference between Orthocryl LC and Enlight light cure composite material (p=0.854). Conclusion Both Orthocryl LC and Enlight light cure composite materials are less cytotoxic when compared to the self-cure acrylic resin material and can be used to fabricate the nasal stent component for infants with cleft defects, undergoing NAM procedure.

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BACKGROUNDS: Nasoalveolar molding (NAM) application is among presurgical management (PSM) techniques used for infants with cleft lip and palate (CLP). It helps to approximate the palatal cleft and to reshape the nasoalveolar complex prior to primary lip repair. This study aimed to explore types of PSM and the dental speciality provision for infants with CLP in Baghdad. The status of NAM usage and surgeons' perceptions toward NAM usage were assessed. MATERIALS AND METHODS: This is a cross-sectional paper-based questionnaire study that collected responses of surgeons perform primary lip and nose repair regarding PSM. The questionnaire was distributed amongst public and private hospitals in Baghdad. Twenty surgeons were enrolled (only those surgeons who perform primary repair for infants with CLP); two females and eighteen males. RESULTS: The majority of participants' responses suggested that the majority of infants with CLP were provided with baby feeding plates and lip straps. Six surgeons reported that a percentage of their patients who have been provided with NAM. PSM in Baghdad was mostly supplied by orthodontists and plastic surgeons, and the next most likely providers were prosthodontists. 82.35% of the surgeons found that primary surgical repair procedures were easier with NAM than for the other infants. The rest have not perceived any differences. CONCLUSIONS: Orthodontists, surgeons and prosthodontists were involved in providing PSM. Baby feeding plates and lip straps were the most common PSM in Baghdad, although NAM is not uncommon. Most surgeons believe that using NAM made surgical procedures easier and permitted the prediction of surgical outcomes.

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OBJECTIVE: Information regarding how caregivers cope when using presurgical infant orthopedic (PSIO) appliances is sparse. This study aimed to understand caregivers' perspectives and experiences with contemporary PSIO treatment. DESIGN: PSIO videos shared on the YouTube™ platform were used as the data source. Videos with caregivers were identified (n = 21) and portions with caregiver narratives were transcribed. This was followed by the application of a six-step thematic analysis as conceptualized by Braun and Clarke (2006, 2019). RESULTS: Two themes were identified from the caregiver narratives in the PSIO videos. The Family Journey theme included reaction to diagnosis, choice of center, burden of care, care commitment, coping, and testimonials. The Information theme included PSIO techniques and PSIO benefits. CONCLUSION: Multifaceted challenges and coping strategies were described by caregivers during the PSIO phase. Caregivers remained committed to treatment despite the burden of care, were motivated by an understanding of the benefits of PSIO, and customized care based on their individual strengths and needs. Study results can help providers gain an understanding of what caregivers experience outside the clinical environment.

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Since its inception in Europe in the 1950s, alveolar molding treatment for neonates with complete cleft lip and palate has undergone significant evolution in both design and application methodology, demonstrating effectiveness in normalizing the alveolar cleft and nasal shape. However, excessively wide alveolar clefts accompanied by disproportionately wide total maxillary arch pose significant challenges when utilizing conventional alveolar molding methods involving cyclical adding and grinding of acrylic on molding plates. The current report introduces a novel alveolar molding method named Biocreative Alveolar Molding Plate Treatment (BioAMP), which can normalize the maxillary alveolar cleft and arch shape without laborious conventional acrylic procedures. BioAMP sets the target arch form and provides unrestricted space for natural growth of the maxillary alveolar bones while systematically reducing the total maxillary arch width in precise increments. Two exemplary cases are presented as proof-of-concept, showcasing the clinical innovation of BioAMP.

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This study aims to analyze long-term effects of nasoalveolar molding (NAM) as a part of cleft primary management protocols on nasolabial aesthetics for patients with non-syndromic cleft lip and palate by conducting a systematic review and meta-analysis. Six electronic databases and two journals were searched up to July 2023. Studies comparing nasolabial outcomes between NAM and non-NAM protocols were selected for further analysis. Nasolabial aesthetics were the outcome of interest. Data extraction, methodological quality assessment, risk of bias assessment, meta-analysis and subgroup analysis were performed. Seven retrospective cohort studies were selected for a qualitative review and four for a quantitative analysis. The risk of bias assessment was moderate for most studies. Only studies utilizing the Asher-McDade rating (AMR) were included for meta-analyses. The protocols with NAM exhibited a significantly lower AMR score for vermillion border than other protocols. AMR scores for nasal form and nasal symmetry from protocols with NAM were significantly lower than protocols without any pre-surgical infant orthopaedics (PSIO) but not significantly different from protocols with other PSIO techniques. The AMR score for nasolabial profile from protocols with NAM was not significantly different from other protocols. However, subgroup analysis demonstrated that protocol combining NAM and primary rhinoplasty significantly lowered AMR scores for nasal form, nasal symmetry and nasolabial profile. For patients with unilateral cleft lip with or without palate (UCLP), this study found that a protocol combining NAM and primary rhinoplasty improved nasolabial outcomes while a protocol with NAM alone offered only limited benefits. For patients with BCLP, the available evidence remains inconclusive. Performing NAM in combination with primary rhinoplasty improves nasolabial aesthetics in patients with UCLP. PROSPERO (CRD4202128384).

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BACKGROUND: Nasoalveolar molding (NAM) is a presurgical orthopedic technique used in the management of cleft lip and palate deformities. Despite the widespread use of NAM therapy, there is a need for further investigation to assess its specific effects on arch dimensions and malocclusion characteristics. AIM: To evaluate the effects of NAM therapy on maxillary arch dimensions and malocclusion characteristics in patients with unilateral cleft lip and palate (UCLP) and bilateral cleft lip and palate (BCLP). DESIGN: Patients in primary dentition were referred to the Institutional Department of Orthodontics. The NAM group consisted of 21 patients with UCLP (mean age 4.7 ± 0.7 years) and 12 patients with BCLP (mean age 4.8 ± 0.7 years). Sixteen patients with UCLP (mean age 4.9 ± 0.9 years) and five patients with BCLP (mean age 5.4 ± 1.1 years) were included in the non-NAM group. The plaster models of all patients were digitized. Dental arch dimensions and malocclusion characteristics were analyzed via digital software. One-way ANOVA with Bonferroni correction was used for statistical analysis. RESULTS: Intercanine and intermolar widths showed statistically significant differences according to the cleft type (p < .01). There was no statistically significant effect of NAM therapy on maxillary arch parameters and malocclusion characteristics (p > .05). The prevalence of anterior crossbite was 12.1% in the NAM group and 23.8% in the non-NAM group. CONCLUSION: NAM therapy did not affect the maxillary arch dimensions and malocclusion characteristics in patients with UCLP and BCLP. The cleft type was the main factor, leading to a significant difference in maxillary widths.

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Introduction: Cleft lip and palate rank third among congenital defects, demanding early intervention for correction. Aim: To describe the results obtained with the use of nasoalveolar molding (NAM) and lip adhesion in patients with complete cleft lip-alveolus-palate, treated in the Maxillofacial Surgery service of the Pediatric Hospital of Matanzas between 2010 and 2020. Methods: An observational, descriptive, prospective research was carried out, in a universe of 16 patients with a diagnosis of complete cleft lip-alveolus-palate, treated in the Maxillofacial Surgery Service of Matanzas pediatric hospital during the period from January 2010 to December 2020, determining reference points to perform linear measurements that represented the study variables, both in patients treated only with nasoalveolar molding and in those in whom the nasoalveolar molding-lip adhesion binomial was used. Results: With the exclusive use of nasoalveolar molding, there was a significant reduction of the palatal cleft in all patients under study, with increase in maxillary and hemi-maxillary transverse dimension, as well as a significant reduction of the alveolar cleft. The total reduction of the alveolar cleft was only achieved by combining lip adhesion with nasoalveolar molding. Conclusion: The nasoalveolar molding-lip adhesion combination constitutes an effective binomial in the treatment of complete cleft lip-alveolus-palate.

Introducción: Las fisuras de labio y paladar ocupan el tercer lugar entre los defectos congénitos, demandando una temprana intervención para su corrección. Objetivo: Describir los resultados del empleo del moldeo nasoalveolar y la adhesión labial en pacientes con fisura labio-alveolo-palatina completa, atendidos en el Servicio de Cirugía Maxilofacial del hospital pediátrico de Matanzas, entre 2010 y 2020. Métodos: Se realizó una investigación observacional, descriptiva, prospectiva, en un universo de 16 pacientes con diagnóstico de fisura labio-alveolo-palatina completa, atendidos en el Servicio de Cirugía Maxilofacial del hospital pediátrico de Matanzas, durante el período comprendido de enero de 2010 a diciembre de 2020, determinándose puntos de referencia para realizar mediciones lineales que representaron las variables de estudio, tanto en pacientes atendidos solo con moldeo nasoalveolar como en los que se empleó el binomio moldeo nasoalveolar-adhesión labial. Resultados: Con el empleo exclusivo del moldeo nasoalveolar, existió una significativa reducción de la hendidura palatina en los pacientes estudiados, con incremento de la dimensión transversal maxilar y hemimaxilar, así como una significativa reducción de la hendidura alveolar. La reducción total de la hendidura alveolar solo se logró al combinar la adhesión labial con el moldeo nasoalveolar. Conclusión: La combinación moldeo nasoalveolar-adhesión labial constituye un binomio efectivo en el tratamiento de la fisura labio-alveolo-palatina completa.

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Unilateral complete cleft lip and palate (UCCLP) is one of the most severe clinical subphenotypes among nonsyndromic cleft lip and/or palate (NSCL/P), that complicates surgical repair operations. Presurgical nasoalveolar molding (PNAM) is a technique used to reshape the nose, lip and alveolar bone of infants with UCCLP before surgery (the modified Mohler rotation advancement cheiloplasty and two flap palatoplasty), with the potential to facilitate surgical repair. However, the effectiveness of PNAM treatment is still a matter of debate. In this paper, the 3Shape scanning system and 3dMD stereophotography were used to assess the short-term and long-term effects of PNAM treatment on the dental arch morphology and nasolabial features of patients with UCCLP, respectively. The findings indicated that PNAM treatment negatively affects both short-term and long-term dental arch shape compared to the treatment without PNAM, particularly in terms of limiting the transverse width of the maxillary canine-to-midline. Regarding the nasal and labial symmetry, PNAM improves the symmetry of the nasal alae in patients over 7 years old and the symmetry of the lip in patients under 7 years old. Moreover, UCCLP patients who received PNAM treatment exhibited a shorter and wider shape of the nostril on the cleft side compared to those without PNAM treatment. In clinical practice, the multidisciplinary team should carefully consider the advantages and disadvantages of the outcomes of PNAM treatment when treating infants with cleft lip and palate.

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OBJECTIVE: This study aims to evaluate the parents' attitude and their perception regarding the management of orofacial cleft (OFC) children with presurgical nasoalveolar molding (PNAM), DynaCleft and/or feeding obturators. MATERIAL AND METHODS: A cross-sectional, descriptive and observational retrospective survey-based study was conducted among parents of OFC children treated with PNAM, DynaCleft and/or feeding obturators who attended a primary dental health care center in Al-Madinah, Saudi Arabia, from 2019 to 2023. A validated questionnaire was used after translating it from English to Arabic. The questionnaire consisted of 32 questions divided into two sections. The first section covers parents' sociodemographic data and OFC risk factors. The second section evaluates the parents' perception regarding the use of presurgical orthopedics (PSO) for OFC repair. The questionnaire was completed through telephone interviews carried out by two investigators with the parents of OFC children. RESULTS: Out of 142 parents of OFC children, only 40 parents and their children met the inclusion criteria of the study. Most parents (95%) reported their satisfaction with the treatment and stated that they would encourage other parents of OFC children to use PSO. CONCLUSION: This study concluded that parents of OFC children had a positive attitude toward PSO treatment. Based on the positive outcomes of PSO treatment reported in the current study and previous literature, PSO should be considered as a routine treatment in the early management of orofacial clefts.

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Background and Objectives: The traditional approach in managing wide cleft lip deformities involves presurgical nasoalveolar molding (NAM) therapy followed by surgical cleft lip repair between three and six months of age. This institution has implemented an early cleft lip repair (ECLR) protocol where infants undergo primary cleft lip repair between two and five weeks of age without NAM. This study aims to present this institution's ECLR repair protocol over the past eight years from 188 consecutive patients with unilateral or bilateral CL/P deformity. Materials and Methods: Retrospective review was conducted at Children's Hospital Los Angeles evaluating patients who underwent ECLR before three months of age and were classified as American Society of Anesthesiologists (ASA) class I or II from 2015-2022. Anthropometric analysis was performed, and pre- and postoperative photographs were evaluated to assess nasal and lip symmetry. Results: The average age at cleft lip repair after correcting for gestational age was 1.0 ± 0.5 months. Mean operative and anesthetic times were 120.3 ± 33.0 min and 189.4 ± 35.4, respectively. Only 2.1% (4/188) of patients had postoperative complications. Lip revision rates were 11.4% (20/175) and 15.4% (2/13) for unilateral and bilateral repairs, respectively, most of which were minor in severity (16/22, 72.7%). Postoperative anthropometric measurements demonstrated significant improvements in nasal and lip symmetry (p < 0.001). Conclusions: This analysis demonstrates the safety and efficacy of ECLR in correcting all unilateral cleft lip and nasal deformities of patients who were ASA classes I or II. At this institution, ECLR has minimized the need for NAM, which is now reserved for patients with bilateral cleft lip, late presentation, or comorbidities that preclude them from early repair. ECLR serves as a valuable option for patients with a wide range of cleft severity while reducing the burden of care.

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OBJECTIVES: Unilateral complete cleft lip and palate (UCCLP) is one of the most severe clinical subtypes among cleft lip and palate (CLP), making repair surgery and subsequent orthodontic treatment particularly challenging. Presurgical nasoalveolar molding (PNAM) has shown conflicting and heterogeneous results in the treatment of UCCLP patients, raising questions about whether the diversity in alveolar anatomical morphology among these patients plays a role in the effectiveness of PNAM treatment. MATERIALS AND METHODS: We collected 90 digital maxillary models of infants with UCCLP and performed mathematical clustering analysis, including principal component analysis (PCA), decision tree modeling, and area under the ROC Curve (AUC) analysis, to classify alveolar morphology and identify key measurements. We also conducted clinical evaluations to assess the association between the alveolar morphology and CLP treatment outcomes. RESULTS: Using mathematical clustering analysis, we classified the alveolar morphology into three distinct types: average form, horizontal form, and longitudinal form. The decision tree model, AUC analysis, and comparison analysis revealed that four measurements (Trans ACG-ACL, ML length, MG length and Inc length) were essential for clustering the alveolar morphology of infants with UCCLP. Furthermore, the blinded clinical evaluation indicated that UCCLP patients with alveolar segments of horizontal form had the lowest treatment outcomes. CONCLUSION: Overall, our findings establish a novel quantitative classification system for the morphology of alveolar bone in infants with UCCLP and suggest that this classification may be associated with the outcomes of CLP treatment. CLINICAL RELEVANCE: The multidisciplinary CLP team should thoroughly evaluate and classify the specific alveolar morphology when administering PNAM to infants with UCCLP.

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