Treatment outcomes of pre-surgical infant orthopedics in patients with non-syndromic cleft lip and/or palate: A systematic review and meta-analysis of randomized controlled trials

Abstract

BackgroundNon-syndromic clefts lip and/or palate (CL/P) defects may have manifold significant and detrimental consequences for the affected individuals and their family environment. Although the use of pre-surgical infant orthopedics (PSIO) was introduced as a means to improve management and treatment outcomes, there still remains a controversy.ObjectiveTo investigate the effectiveness of PSIO in patients with non-syndromic CL/P and evaluate the quality of the available evidence.Search methodsSearch without restrictions, together with hand searching, until May 2016.Selection criteriaRandomized clinical trials investigating the effects of pre-surgical infant orthopedic appliances.Data collection and analysisFollowing study retrieval and selection, data extraction and individual study risk of bias assessment using the Cochrane Risk of Bias Tool took place. The overall quality of the available evidence was assessed with the Grades of Recommendation, Assessment, Development and Evaluation approach.ResultsFinally 20 papers (3 unique trials) were identified, involving a total of 118 patients with unilateral complete CL/P and 16 with cleft of the soft and at least two thirds of the hard palate. Eight publications were considered as being of low, four of unclear and eight of high risk of bias. In general, the investigated appliances did not present significant effects when compared to each other or to no treatment in terms of feeding and general body growth, facial esthetics, cephalometric variables, maxillary dentoalveolar variables and dental arch relationships, speech and language evaluation, caregiver-reported outcomes, economic evaluation, as well as, adverse effects and problems. Overall, the quality of the available evidence was considered low.ConclusionsThe 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 order to reach more robust relevant recommendations for management decisions in individual cases.

Surgical Nasoalveolar Molding: A Rational Treatment for Bilateral Cleft Lip Nose and Systematic Review

“…16 Different studies (including meta-analysis) have described the absence of scientific evidence supporting the use of NAM for cleft lip nose repair. 11 , 17 – 19 Significant relapse of the deformity has been observed after using nasal moldings, 20 and good outcomes were observed only in combination with primary rhinoplasty. 21 – 23 The Taiwanese group from Chang Gung University demonstrated that nasal molding has a short-term effect, and only surgery may guarantee a long-term effect.…”

“…The last meta-analysis published by Hosseini in 2017 concluded that there is limited evidence to support the short- or long-term effectiveness of presurgical NAM in cleft lip and palate patients. 11 …”

The Surgical Nasoalveolar Molding: A Rational Treatment for Unilateral Cleft Lip Nose Deformity and Literature Review

“…Different reviews and meta-analysis have been published during the last years addressing the effects of NAM in cleft lip and palate surgery. 33 , 34 A 2017 meta-analysis by Hosseini et al 34 suggested further research to reach more relevant recommendations. Two recent reviews by Maillard et al 35 in 2017 and Liu et al 36 in 2018 concluded that the use of NAM offers positive aesthetical effects.…”

Intraoral Digital Impression Technique for a Neonate With Bilateral Cleft Lip and Palate

“…There remains ongoing debate as to the efficacy of presurgical intervention in the management of CLP. Aspects such as cost–benefit of treatment and the influence of PSO treatment on facial growth and arch form in the longer term remain controversial with the current evidence being of low quality to make any conclusive recommendations (Uzel and Alparslan, 2011; Hosseini et al, 2017). Although further high-quality studies are required, there is an emerging body of evidence that have highlighted promising results from the use of techniques such as nasoalveolar molding (Spengler et al, 2006; Abbott and Meara, 2012).…”