Journal of stomatology, oral and maxillofacial surgery · 2026
Effectiveness of digitally- versus conventionally-fabricated nasoalveolar molding appliances for presurgical approximation of complete cleft lip and palate: A systematic review and meta-analysis of randomized controlled trials.
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Velickovic Aleksandra, Rossouw P Emile, Javed Fawad
Аннотация
BACKGROUND: Presurgical nasoalveolar molding (NAM) has become an integral component of comprehensive cleft lip and palate (CLP) care. The aim of the present systematic review and meta-analysis is to assess the efficacy of digitally versus conventionally fabricated NAM appliances for presurgical approximation of complete CLP.
METHODS: The focused research question is "In patients with CLP, does the use of digitally-fabricated NAM appliances yield superior presurgical cleft approximation outcomes than conventionally-fabricated NAM appliances?" Literature search was conducted in accordance with PRISMA guidelines. Indexed databases and Google-Scholar were searched without language or time restrictions up to December 2025. Boolean operators were used during the literature search. Hand searching of relevant original and review articles was also performed. Risk of bias (RoB) was assessed using the Cochrane RoB tool, and certainty of evidence (CoE) was evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach. Disagreements were resolved through discussion. Meta-analyses were performed using random-effects models when outcomes were sufficiently comparable.
RESULTS: Five RCTs were included. In these RCTs, 12-30 infants aged 5-45 days, were included. Two and three RCTs were based on unilateral and bilateral CLP, respectively. Meta-analysis demonstrated no significant differences between digital and conventional NAM appliances for several presurgical outcomes, including nostril height, cleft width, mid-arch width, and prolabial deviation. Digitally fabricated NAM appliances were associated with significantly greater improvement in columella deviation and a greater reduction in arch length than conventional NAM appliances (P<0.001). Four RCTs were based on power-adjusted data. The RoB demonstrated some concerns in four RCTs and CoE ranged from moderate to low, primarily due to imprecision, heterogeneity, and methodological limitations.
CONCLUSION: Due to the limited number of RCTs and the high heterogeneity of the evidence, the effectiveness of digitally- versus conventionally-fabricated NAMs is debatable. Further well designed, power-adjusted RCTs with more robust sample sizes are needed to draw more valid conclusions.
METHODS: The focused research question is "In patients with CLP, does the use of digitally-fabricated NAM appliances yield superior presurgical cleft approximation outcomes than conventionally-fabricated NAM appliances?" Literature search was conducted in accordance with PRISMA guidelines. Indexed databases and Google-Scholar were searched without language or time restrictions up to December 2025. Boolean operators were used during the literature search. Hand searching of relevant original and review articles was also performed. Risk of bias (RoB) was assessed using the Cochrane RoB tool, and certainty of evidence (CoE) was evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach. Disagreements were resolved through discussion. Meta-analyses were performed using random-effects models when outcomes were sufficiently comparable.
RESULTS: Five RCTs were included. In these RCTs, 12-30 infants aged 5-45 days, were included. Two and three RCTs were based on unilateral and bilateral CLP, respectively. Meta-analysis demonstrated no significant differences between digital and conventional NAM appliances for several presurgical outcomes, including nostril height, cleft width, mid-arch width, and prolabial deviation. Digitally fabricated NAM appliances were associated with significantly greater improvement in columella deviation and a greater reduction in arch length than conventional NAM appliances (P<0.001). Four RCTs were based on power-adjusted data. The RoB demonstrated some concerns in four RCTs and CoE ranged from moderate to low, primarily due to imprecision, heterogeneity, and methodological limitations.
CONCLUSION: Due to the limited number of RCTs and the high heterogeneity of the evidence, the effectiveness of digitally- versus conventionally-fabricated NAMs is debatable. Further well designed, power-adjusted RCTs with more robust sample sizes are needed to draw more valid conclusions.