Evaluation of the Clinical Effectiveness of Naso-alveolar Molding (NAM) Versus Computer Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Cleft Lip and Palate
• Interventions: Device: Naso-alveolar molding (NAM); Device: Computer aided design NAM (CAD/NAM)

• Registration Number: NCT02881606
• Lead Sponsor: Cairo University

Brief Summary

Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM (CAD/NAM). The aim of the study is to compare between short term clinical effects of both interventions as regards alveolar alignment, nasal esthetics and interlabial gap.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-29
• Study Start: 2016-12
• Primary Completion: 2019-03
• Study Completion: 2019-05
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-01
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Bilateral cleft lip and palate

Exclusion Criteria

Patients without cleft palate Unilateral cleft lip Patients having systemic medical problems that contraindicate NAM treatment Patients with history of previous presurgical infant orthopedics Patients with history of any surgical procedures (ex: lip adhesion)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naso-alveolar molding (NAM)	Naso-alveolar molding (NAM)	Active plates and nasal stents (Grayson method)
Computer aided design NAM (CAD/NAM)	Computer aided design NAM (CAD/NAM)	Computer aided design active plates and nasal stents

Primary Outcome Measures

Name	Time	Method
Alveolar alignment	5-6 months	Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments

Secondary Outcome Measures

Name	Time	Method
Nasal and labial esthetics	5-6 months	Reference points, lines and planes on standardized photos recording the collumellar length, symmetry of nostrils and interlabial gap

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine, Cairo University; 🇪🇬 Cairo, Egypt