Chewing with a cleft palate: a randomized controlled trial. Effect of timing of surgical closure of the palate on mastication in infants with clefts.

Objectives: To evaluate the effect of surgical timing of palatal closure on overall masticatory function in infants with cleft lip and/or palate (CL/P).

Materials and methods: In this randomized controlled trial, 60 children with cleft lip and/or palate (CL/P) were assessed at the Wilhelmina Children's Hospital, University Medical Center Utrecht, the Netherlands. Participants were randomly assigned to early closure (Group A: 6-8 months) or late closure (Group B: 10-12 months). Chewing function was evaluated at 9, 13, and 17 months of age using the Mastication Observation and Evaluation (MOE) instrument, which scores eight components of mastication.

Results: No statistically significant differences were found in total MOE scores between groups at any time point. However, at 17 months, Group B showed significantly better lateral tongue movement than Group A (mean = 2.72, SD = 0.53 vs. mean = 2.45, SD = 0.51; p = .047).

Conclusions: Early palatal closure (6-8 months) does not improve overall mastication compared to late closure (10-12 months) in the first 17 months of life.

Clinical relevance: Research on mastication in children with CL/P is limited. This study provides novel insights into functional outcomes of palatal surgery, supporting evidence-based refinement of cleft treatment protocols.

Trial registration number: The CLEFED study was approved by the Medical Ethics Committee of the University Medical Center Utrecht, The Netherlands (registration no: NTR3275). Date of registration: November 2011.

Trial register: https://www.trialregister.nl/trial/3125 (trial number: NTR3275).