Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial
1 other identifier
interventional
14
0 countries
N/A
Brief Summary
Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed aligners in order to evaluate its effect on Nasoalveolar complex.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
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
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 4, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 25, 2017
April 1, 2017
5 months
January 4, 2017
April 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Parents' satisfaction
It will be measured by questionnaire
3 months
Secondary Outcomes (3)
Changes in Nasal morphology( Height, width, angulation of columella
3 months
Changes in Interlabial gab
3 months
Changes in Maxillary arch dimension
3 months
Study Arms (2)
Vacuum formed aligners group
EXPERIMENTALThis group will receive Vacuum formed aligners in addition to taping for 3 Months with follow-up every 1-2 weeks
control group
NO INTERVENTIONThis group will not receive any treatment
Interventions
Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is a modified step in Figueroa's technique.
Eligibility Criteria
You may qualify if:
- Non-syndromic Infants with complete unilateral cleft lip and palate
- Infants less than 3 months of age
- Males and females.
- Infants with displaced alveolus
- Patients whose parents provided written consent for the study.
You may not qualify if:
- Patients above 3 months of age
- Syndromic, malnourished and systemically ill infants.
- Patients with bilateral cleft lip and palate.
- Incomplete Cleft lip.
- Medically compromised patients
- Patient's/guardians who will be unwilling to go through the PNAM therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fatma Abdu Abdelsayed, professor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master student, faculty of oral and dental medicine, Cairo university
Study Record Dates
First Submitted
January 4, 2017
First Posted
January 5, 2017
Study Start
January 1, 2017
Primary Completion
June 1, 2017
Study Completion
December 1, 2017
Last Updated
April 25, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share