Clinical Trial: Nasoalveolar Molding for Egyptian Cleft Lip Palate Infants
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Efficacy of Nasoalveolar Molding Therapy for Treatment of Unilateral Cleft Lip and Palate in Egyptian Infants
Brief Summary:
The cleft lip and palate (CLP) is the commonest craniofacial anomaly worldwide. Nasoalveolar molding (NAM) therapy has emerged in the management of CLP as an early presurgical intervention to provide symmetry to severely deformed nasal cartilage, achieve projection to the flattened nasal tip, provide nonsurgical elevation for the columella, improve alignment of the alveolar ridge, reduce the cleft gap and it could significantly reduce the number of secondary surgeries. Despite that NAM therapy is becoming the treatment option for early cleft care, there is growing debate about its efficacy due to lack of quantitative assessment of these findings. To provide the highest levels of clinical evidence on NAM therapy, there has been international call for Randomized Controlled Clinical Trials.
Statement of the problem: lack of quantitative data about the efficacy of the NAM therapy for unilateral CLP.
Aim of the study: is to develop a standardized non-invasive quantitative assessment for two different techniques of the NAM therapy in Egyptian infants that involves 3D laser scanning/CAD analysis for maxillary geometry, and nasal anthropometric analysis.
Methods Trial design: Prospective randomized controlled clinical trial (RCT). Settings: The RCT will be performed through two phases; (Phase I: A controlled pre and post-RCT that will be designed for the quantitative evaluation of the NAM therapy on the maxillary geometry), and (Phase II: A post-test RCT will be designed for the quantitative evaluation of the NAM therapy on the nasal anthropometry and comparing the outcome with the nasal anthropometry that will be performed to age matched Egyptian norms).
Participants: 30 Egyptian infants with nonsyndromic UCLP will be randomly allo
Detailed Summary:
o Trial Design:
The present randomized controlled clinical trial (RCT) will be performed through two phases:
• RCT- (Phase I)
A controlled pre- and post-clinical trial will be designed for the quantitative evaluation of the NAM therapy on the maxillary geometry.
• RCT- (Phase II)
A post-test controlled clinical trial will be designed for the quantitative evaluation of the NAM therapy on the nasal anthropometry.
Infants with nonsyndromic complete unilateral cleft lip and palate UCLP will be selected from those admitted to the Maxillofacial and Plastic surgery department- Faculty of Dentistry- Alexandria University based on the inclusion and exclusion criteria.
o Sample size:
Using a power of 80% to detect clinically meaningful difference at the cleft gap distance (D1-D2) before and after applying NAM therapy = 5.8, SD (standard deviation) =3.4, effect size=1.2 and α=0.05. The minimal required sample size was calculated to be twelve per group (increased to fifteen to avoid drop outs).
The sample size was calculated using G*Power software.
o Randomization:
The randomization for a total of 45 infants will be done as following:
Thirty infants with nonsyndromic UCLP will be randomly allocated by using closed envelop allocation concealment method. However, the fifteen normal infants will be only randomly selected.
Sponsor: Alexandria UniversityCurrent Primary Outcome: Three dimensional (3D) change in the maxillary geometry. [ Time Frame: (T0 baseline; pre-NAM therapy), (T2 during NAM therapy) and (T3 before surgery) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change in the nasal anthropometry. [ Time Frame: ( T"0 = 1 days post-surgery) and (T"1= 6 months post-surgery). ]
Original Secondary Outcome: Same as current
Information By: Alexandria University
Dates:
Date Received: January 18, 2017
Date Started: December 2016
Date Completion: September 2017
Last Updated: April 29, 2017
Last Verified: April 2017
