Treatment Outcomes of Pre-Surgical Infant Orthopedicsin Patients with Non-Syndromic Cleft Lip and/Or Palate: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract

Aim: To investigate the effectiveness of pre-surgical infant orthopedics in patients with non-syndromic cleft lip and/or palate and evaluate the quality of the available evidence.

Materials and methods: An electronic search without restrictions for published and unpublished literature, together with hand searching, was carried out. Randomized controlled trials (RCTs) investigating the effects of pre-surgical infant orthopedic appliances reviewed. The risk of bias was assessed using the Cochrane Collaboration’s Risk of Bias assessment tool for RCTs and the quality of evidence assessed according the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.

Results: The initially identified 1,043 records were finally reduced to 20 full-text reports concerning a total of 118 patients with unilateral complete cleft lip and palate and 16 with cleft of the soft and at least two thirds of the hard palate. Eighteen of the eligible records comprised a part of a larger trial. Eight publications were considered as being of low, four of unclear and eight of high risk of bias. iii In general, the investigated appliances did not present significant effects when compared to each other or to no treatment in terms of feeding characteristics and general body growth, facial esthetics, cephalometric variables, maxillary dentoalveolar variables and dental arch relationships, speech and language related variables, caregiver-reported outcomes, economic evaluation related outcomes, as well as, adverse effects and problems related to the appliances or the applied procedures. Overall, the quality of the available evidence was considered low.

Conclusions: The aforementioned findings could provide initial guidance in the clinical setting. However, given the multitude of parameters which may have affected the results, good practice would suggest further research in the respective field, in order to arrive at more robust relevant recommendations for management decisions in individual cases.