Two Methods of Lip Taping as a Presurgical Orthopedic Appliance
Effectiveness of Two Methods of Lip Taping as a Presurgical Orthopedic in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
1 other identifier
interventional
24
1 country
1
Brief Summary
A randomized clinical trial to compare the effectiveness of two methods of lip taping as a presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.
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 2023
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
Study Start
First participant enrolled
January 12, 2023
CompletedFirst Submitted
Initial submission to the registry
March 18, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedApril 8, 2024
April 1, 2024
1.1 years
March 18, 2023
April 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of maxillary arch dimension change
To evaluate the effect of the lip taping as a presurgical orthopedic on the maxillary arch dimensions for infants with bilateral cleft using two different types of medical taping.
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Secondary Outcomes (3)
Assessment of Linear measurement change
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Assessment of Angular measurement change
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Assessment of Parents Perception and experience
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Study Arms (2)
Passive lip taping
EXPERIMENTALWill receive passive baby feeding plate and conventional steri strip
Custom-made tape
EXPERIMENTALwill receive passive baby feeding plate and custom-made tape (Steri Srip and orthodontic elastics)
Interventions
Steri strip tape and passive baby feeding plate Two methods of lip taping will be used with passive baby feeding plate. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.
Eligibility Criteria
You may qualify if:
- Non-Syndromic infants with complete bilateral cleft lip and palate.
- Both sexes.
- Age range from 1-30 day
You may not qualify if:
- Infants with systemic syndromes.
- infants with unilateral cleft
- infants whom parents refuse to consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
College of Dentistry
Baghdad, Al-Rusaffa, 01110, Iraq
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
- Professor
Study Record Dates
First Submitted
March 18, 2023
First Posted
April 3, 2023
Study Start
January 12, 2023
Primary Completion
March 1, 2024
Study Completion
May 1, 2024
Last Updated
April 8, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share