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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

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