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Background: Cleft lip and palate (CLP) are among the most common congenital anomaly that affects up to 33,000 newborns in India every year. Nasoalveolar moulding (NAM) is a non-surgical treatment performed between 0 and 6 months of age to reduce the cleft and improve nasal aesthetics prior to lip surgery. The NAM treatment has been a controversial treatment option with 51% of the cleft teams in Europe, 37% of teams in the USA and 25 of cleft teams in India adopting this methodology. This treatment adds to the already existing high burden of care for these patients. Furthermore, the supporting evidence for this technique is limited with no high-quality long-term clinical trials available on the effectiveness of this treatment., Method: The NAMUC study is an investigator-initiated, multi-centre, single-blinded randomized controlled trial with a parallel group design. The study will compare the effectiveness of NAM treatment provided prior to lip surgery against the no-treatment control group in 274 patients with non-syndromic unilateral complete cleft lip and palate. The primary endpoint of the trial is the nasolabial aesthetics measured using the Asher McDade index at 5 years of age. The secondary outcomes include dentofacial development, speech, hearing, cost-effectiveness, quality of life, patient perception, feeding and intangible benefits. Randomization will be carried out via central online system and stratified based on cleft width, birth weight and clinical trial site., Discussion: We expect the results from this study on the effectiveness of treatment with NAM appliance in the long term along with the cost-effectiveness evaluation can eliminate the dilemma and differences in clinical care across the globe., Trial Registration: ClinicalTrials.gov CTRI/2022/11/047426 (Clinical Trials Registry India). Registered on 18 November 2022. The first patient was recruited on 11 December 2022. CTR India does not pick up on Google search with just the trial number. The following steps have to be carried out to pick up. How to search: ( https://ctri.nic.in/Clinicaltrials/advsearch.php -use the search boxes by entering the following details: Interventional trial > November 2022 > NAMUC)., (© 2024. The Author(s).)

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., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background  The objective of our study was to derive an objective assessment scale for three-dimensional (3D) qualitative and quantitative evaluation of secondary alveolar bone grafting (SABG) using cone-bone computed tomography (CBCT) in patients with unilateral cleft lip and palate (UCLP). Methods  CBCT scans for pre- and 3-month post-SABG were reviewed for bone volume, height, width, and density of the bony bridge formed in the cleft defect in 20 patients with UCLP. Basic descriptive and principal component analysis was used to extract the various sub-components of the scale. Spearman's correlation was used to check the validity of the scale, and intra-class coefficient (ICC) and Cronbach's α were calculated to establish the reliability and retest applicability of the scale. Results  Each CBCT scan was assessed in five areas: cementoenamel junction (CEJ), root apex, root midpoint, 3 and 6 mm below CEJ, and tabulated in percentiles of 20, 25, 40, 50, 60, and 75 for all the parameters (bone volume, density, and width). These scores were validated when correlated to the scale given by Kamperos et al. Cronbach's α for the domains demonstrated acceptable to excellent internal consistency. The ICC showed good test-retest reliability having a range of scores from 0.89 to 0.94. Conclusion  The proposed scale for the 3D assessment of SABG in patients with UCLP provides gradation for the objective assessment of the bony bridge. This gradation enables the qualitative and quantitative assessments of the bony bridge, thus allowing each clinician to judge SABG more conclusively., Competing Interests: Conflict of Interest None declared., (Association of Plastic Surgeons of India. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. ( https://creativecommons.org/licenses/by-nc-nd/4.0/ ).)