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

NCT ID: NCT02881606

Last Updated: 2019-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-05-31

Brief Summary

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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

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Conditions

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Cleft Lip and Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
Blinding was done for the plastic surgeon (care provider) during lip repair and for the outcome assessor

Study Groups

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Naso-alveolar molding (NAM)

Active plates and nasal stents (Grayson method)

Group Type ACTIVE_COMPARATOR

Naso-alveolar molding (NAM)

Intervention Type DEVICE

Computer aided design NAM (CAD/NAM)

Computer aided design active plates and nasal stents

Group Type ACTIVE_COMPARATOR

Computer aided design NAM (CAD/NAM)

Intervention Type DEVICE

Interventions

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Naso-alveolar molding (NAM)

Intervention Type DEVICE

Computer aided design NAM (CAD/NAM)

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

7 Days

Maximum Eligible Age

60 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Noha Ali El Ashmawi

Assistant lecturer at orthodontic department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Oral and Dental Medicine, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CEBD-CU-2016-08-184

Identifier Type: -

Identifier Source: org_study_id

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