CompletedNot 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

Egypt28 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range7 Days – 60 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Alveolar alignment

Timeframe: 5-6 months

Trial details

NCT IDNCT02881606

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03

View on ClinicalTrials.gov More Cleft Lip and Palate trials