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NCT02845193 Clinical Trial

Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial

Cleft Lip and Palate Clinical Trial

Official title:
Effect of A Novel (Modified Grayson) Technique for Nasoalveolar Molding and Taping on Parents' Satisfaction and Short Term Treatment Outcomes in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02845193
Other study ID # CEBD-2016-07-172
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date April 2019

Study information
Verified date July 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.

Description:

In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date April 2019
Est. primary completion date September 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 30 Days
Eligibility Inclusion Criteria:

1. Infants with age range from 7 - 30 days.

2. Unilateral complete cleft lip and alveolus.

3. Presence of unilateral cleft palate.

4. Medically free subjects.

5. Both males and females.

Exclusion Criteria:

1. Patients older than 30 days.

2. Syndromic patients with other defects in addition to cleft lip and palate.

3. Patients with bilateral cleft lip and palate.

4. Incomplete Cleft lip.

5. Medically compromised patients.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Modified Nasoalveolar molding
Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is routine step in Grayson's nasoalveolar molding technique).
• Taping
Infants will receive a tape only on the upper lip segments to mold it to touch each other.
• CAD/NAM
computer aided design NAM

Locations
Country Name City State
Egypt Faculty of Dentistry Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Parents' satisfaction It will be assessed using Questionnaire. 3 months
Secondary Nasal Esthetics: a- Nostril height It will be measured in mm by Digital ruler on the images using a software. 3 months
Secondary Nasal Esthetics: b- Nostril width It will be measured in mm by Digital ruler on the images using a software. 3 months
Secondary Nasal Esthetics: c- Nasal sill height It will be measured in mm by Digital ruler on the images using a software. 3 months
Secondary Nasal Esthetics: d- Nostril area It will be measured on the images in mm 2 (square) using a software measuring area. 3 months
Secondary Interlabial gap It will be measured in mm by Digital ruler on the images using a software. 3 months
Secondary Maxillary Arch Dimension It will be measured as distances in mm between landmarks identified on the dental models assessing the anterioposterior, transverse and vertical changes. 3 months
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