Long-term effects of nasoalveolar molding in non-syndromic bilateral cleft lip and palate patients: a systematic review protocol

OBJECTIVE: This review will investigate the effectiveness of nasoalveolar molding (NAM) in patients with non-syndromic bilateral cleft lip and palate (BCLP), compared to no intervention in patients with non-syndromic BCLP, non-syndromic unilateral cleft lip and palate (UCLP), and non-cleft control subjects in producing morphological changes of the lip, nose, and occlusion, evaluated after a minimum follow-up period of 2 years. INTRODUCTION: Nasoalveolar molding offers benefits in managing cleft patients; however, concerns include hindrance to jaw growth, malocclusion, and soft tissue effects. ELIGIBILITY CRITERIA: Randomized and non-randomized studies evaluating the long-term (minimum follow-up of 2 years after primary cleft lip repair surgery) soft tissue, dental, and skeletal effects of NAM in non-syndromic BCLP patients compared to non-syndromic BCLP patients not undergoing NAM, non-syndromic UCLP patients who underwent NAM, and non-cleft control subjects. METHODS: The review will follow the JBI methodology for systematic review of effectiveness. PubMed, Scopus, Embase (Ovid), VHL Regional Portal (including LILACS), Web of Science Core Collection, Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, ProQuest Health and Medical Collection, MedNar, OpenGrey, and ClinicalTrials.gov will be searched for published and unpublished literature, in any language. Two independent reviewers will screen the titles/abstracts and full-texts. Critical appraisal will be conducted using the standard JBI appraisal tools. Meta-analysis will be conducted for all outcomes, where appropriate, with weighted mean differences for continuous data, and risk ratios for dichotomous data. Certainty of the evidence will be reported using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. REVIEW REGISTRATION: PROSPERO CRD42024510757.