INTRODUCTION: This systematic review aimed to compare the effectiveness of nasoalveolar molding (NAM) treatment with no NAM group for babies with nonsyndromic unilateral cleft lip, alveolus, and palate. METHODS: All relevant studies from 1946 to February 2024 were identified using several sources, including The Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, LILACS, Scopus, EMBASE, MEDLINE (Ovid), and ePUB ahead of publications and nonindexed citations. The criteria for this review were as follows: (1) studies with a randomized controlled trial (RCT) and controlled clinical trial (CCT) design
(2) the target population included patients with nonsyndromic complete unilateral cleft lip, alveolus, and palate
(3) the intervention group received NAM treatment before lip repair, whereas the comparison group did not
and (4) the primary outcome was nasolabial esthetics measured using Asher McDade index. All articles were screened for the title, abstract, and full text independently and in duplicate by 2 reviewers. The quality assessment of RCT was performed using Cochrane's risk of bias tool, and the CCT was assessed using the Risk Of Bias In Nonrandomized Studies of Interventions tool. RESULTS: Out of the 1432 studies retrieved, 2 RCTs and 3 CCTs were included. One RCT was assessed as having a high risk of bias, whereas the other had an unclear risk. All included CCTs were rated as having a high risk of bias. The studies showed a statistically significant reduction in cleft width favoring the NAM group, and 1 study with a high risk of bias reported significantly better long-term intercanine width for NAM. However, none of the included studies examined long-term or short-term nasolabial esthetics or other functional or esthetic outcomes over the long term. CONCLUSIONS: No conclusions can be drawn on the nasolabial esthetics as none of the included studies evaluated this primary outcome in the short or long term. There is low certainty of evidence supporting the short-term effectiveness of NAM for cleft width reduction in patients with complete unilateral cleft lip, alveolus, and palate. Further high-quality studies are needed to evaluate the long-term effectiveness of NAM treatment, enabling clinicians and patients to make informed decisions. REGISTRATION: The protocol for the systematic review was registered with the International Prospective Register of Systematic Reviews from the National Institute for Health Research database (Prospero No. CRD42024503388). FUNDING: This work was supported by the DBT/Wellcome Trust India Alliance Grant (No. IA/CPHS/20/1/505255
awarded to Badri Thiruvenkatachari).