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

Not Applicable

Completed

• Conditions: Cleft Lip and Palate
• Interventions: Device: Modified Nasoalveolar molding; Device: CAD/NAM; Device: Taping

• Registration Number: NCT02845193
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Study Start: 2016-11
• Primary Completion: 2018-09
• Study Completion: 2019-04
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Nasoalveolar molding group	Modified Nasoalveolar molding	This group will receive nasoalveolar molding appliance in addition to taping for 3 Months with follow-up every 2 weeks.
CAD/NAM group	CAD/NAM	Computer Aided Designed Nasoalveolar molding and 3D printed.
Taping group	Taping	Tape will be used alone in this group on the upper lip segments for 3 months with follow-up every 2 weeks.

Primary Outcome Measures

Name	Time	Method
Parents' satisfaction	3 months	It will be assessed using Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Nasal Esthetics: d- Nostril area	3 months	It will be measured on the images in mm 2 (square) using a software measuring area.
Maxillary Arch Dimension	3 months	It will be measured as distances in mm between landmarks identified on the dental models assessing the anterioposterior, transverse and vertical changes.
Nasal Esthetics: a- Nostril height	3 months	It will be measured in mm by Digital ruler on the images using a software.
Nasal Esthetics: b- Nostril width	3 months	It will be measured in mm by Digital ruler on the images using a software.
Nasal Esthetics: c- Nasal sill height	3 months	It will be measured in mm by Digital ruler on the images using a software.
Interlabial gap	3 months	It will be measured in mm by Digital ruler on the images using a software.

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Egypt