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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02845193
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Abd El-Ghafour, 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.

Condition or disease Intervention/treatment Phase
Cleft Lip and Palate Device: Modified Nasoalveolar molding Device: Taping Device: CAD/NAM Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Parents' satisfaction [ Time Frame: 3 months ]
    It will be assessed using Questionnaire.


Secondary Outcome Measures :
  1. Nasal Esthetics: a- Nostril height [ Time Frame: 3 months ]
    It will be measured in mm by Digital ruler on the images using a software.

  2. 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. 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.

  4. 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.

  5. Interlabial gap [ Time Frame: 3 months ]
    It will be measured in mm by Digital ruler on the images using a software.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845193


Locations
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Egypt
Faculty of Dentistry
Cairo, Egypt, 00202
Sponsors and Collaborators
Cairo University
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Responsible Party: Mohamed Abd El-Ghafour, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT02845193    
Other Study ID Numbers: CEBD-2016-07-172
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities