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

July 22, 2019 updated by: Mohamed Abd El-Ghafour, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 00202
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified Nasoalveolar molding group
This group will receive nasoalveolar molding appliance in addition to taping for 3 Months with follow-up every 2 weeks.
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).
Experimental: Taping group
Tape will be used alone in this group on the upper lip segments for 3 months with follow-up every 2 weeks.
Device: Taping
Infants will receive a tape only on the upper lip segments to mold it to touch each other.
No Intervention: Control group
This group will not receive any treatment.
Experimental: CAD/NAM group
Computer Aided Designed Nasoalveolar molding and 3D printed.
Device: CAD/NAM
computer aided design NAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parents' satisfaction
Time Frame: 3 months
It will be assessed using Questionnaire.
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-2016-07-172

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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