NCT02881606CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Alveolar alignment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
Blinding was done for the plastic surgeon (care provider) during lip repair and for the outcome assessor
Eligibility Criteria
- Ages
- 7 Days to 60 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Alveolar alignment
Time Frame: 5-6 months
Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments
Secondary Outcomes
- Nasal and labial esthetics(5-6 months)
Investigators
Noha Ali El Ashmawi
Assistant lecturer at orthodontic department
Cairo University
Study Sites (1)
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