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
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
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2016
CompletedFirst Posted
Study publicly available on registry
July 27, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJuly 23, 2019
July 1, 2019
1.8 years
July 19, 2016
July 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Parents' satisfaction
It will be assessed using Questionnaire.
3 months
Secondary Outcomes (6)
Nasal Esthetics: a- Nostril height
3 months
Nasal Esthetics: b- Nostril width
3 months
Nasal Esthetics: c- Nasal sill height
3 months
Nasal Esthetics: d- Nostril area
3 months
Interlabial gap
3 months
- +1 more secondary outcomes
Study Arms (4)
Modified Nasoalveolar molding group
EXPERIMENTALThis group will receive nasoalveolar molding appliance in addition to taping for 3 Months with follow-up every 2 weeks.
Taping group
EXPERIMENTALTape will be used alone in this group on the upper lip segments for 3 months with follow-up every 2 weeks.
Control group
NO INTERVENTIONThis group will not receive any treatment.
CAD/NAM group
EXPERIMENTALComputer Aided Designed Nasoalveolar molding and 3D printed.
Interventions
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).
Infants will receive a tape only on the upper lip segments to mold it to touch each other.
Eligibility Criteria
You may qualify if:
- Infants with age range from 7 - 30 days.
- Unilateral complete cleft lip and alveolus.
- Presence of unilateral cleft palate.
- Medically free subjects.
- Both males and females.
You may not qualify if:
- Patients older than 30 days.
- Syndromic patients with other defects in addition to cleft lip and palate.
- Patients with bilateral cleft lip and palate.
- Incomplete Cleft lip.
- Medically compromised patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry
Cairo, 00202, Egypt
Related Publications (1)
Abd El-Ghafour M, Aboulhassan MA, El-Beialy AR, Fayed MMS, Eid FHK, Emara D, El-Gendi M. Does Presurgical Taping Change Nose and Lip Aesthetics in Infants with Unilateral Cleft Lip and Palate? A Randomized Controlled Trial. Plast Reconstr Surg. 2022 Dec 1;150(6):1300e-1313e. doi: 10.1097/PRS.0000000000009738. Epub 2022 Sep 20.
PMID: 36126199DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
July 19, 2016
First Posted
July 27, 2016
Study Start
November 1, 2016
Primary Completion
September 1, 2018
Study Completion
April 1, 2019
Last Updated
July 23, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share