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Completed

NCT Number: NCT02881606

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

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.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

7 day–60 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Naso-alveolar molding (NAM)

Device

Computer aided design NAM (CAD/NAM)

Device

Primary outcomes

  1. 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

  1. Nasal and labial esthetics

    Time frame: 5-6 months

    Reference points, lines and planes on standardized photos recording the collumellar length, symmetry of nostrils and interlabial gap

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2016
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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