Trial reportClinical oral investigations2025
Chewing with a cleft palate: a randomized controlled trial. Effect of timing of surgical closure of the palate on mastication in infants with clefts.
Trial report in Clinical oral investigations, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Authors and funding
8 authors.
Funding
Abstract
objectivesTo 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
methodsIn 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.
resultsNo 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).
conclusionsEarly 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).
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