Back to resultsBotulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair
Primary Purpose
Cleft Lip
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Botulinum
Fisher technique
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip
Eligibility Criteria
Inclusion Criteria:
- With mild to severe cleft lip deformity requiring repair.
- Neonates up to 1 year of age.
- Patients with or without cleft palate.
- Systemically healthy patients.
- Patients follow postoperative instructions provided by their legal guardians.
Exclusion Criteria:
- Patients with a syndromic type of cleft lip.
- Patients suffering from relevant systemic and metabolic diseases.
- Patients suffering from immunosuppressive diseases.
- Patients suffering from neuromuscular disorders like Myasthenia Gravis.
- Patients with special needs.
Sites / Locations
- Alexandria Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Outcomes
Primary Outcome Measures
Change in cleft scar
Vancouver Scar Scale: This scale focuses on four parameters:
scar height and thickness, pliability, vascularity, and pigmentation to generate a score ranging from 0 to 13 point
Secondary Outcome Measures
Change in scar width
The scar width is to be measured at two certain points using digital caliper, one point is 1 mm above white line and the second point is 1 mm below nasal
Change in lip height
The lip height measurement will be done using digital caliper at cleft and non-cleft side.
Full Information
NCT ID
NCT05559281
First Posted
September 25, 2022
Last Updated
October 2, 2022
Sponsor
Hams Hamed Abdelrahman
1. Study Identification
Unique Protocol Identification Number
NCT05559281
Brief Title
Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair
Official Title
Evaluation of Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair (Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A cleft lip is a congenital defect resulting from failing to merge developmental processes in the Orofacial region. One of the most common complications surgeons fear after cleft lip repair is a hypertrophic scar. A cleft scar negatively affects a patient's appearance, psychology, and function. Several techniques have been proposed to improve lip scars such as steroid therapy, laser therapy, and silica gel. Despite such efforts, the results were still unsatisfactory. Botulinum Toxin injections may provide a more reliable method
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Botulinum
Intervention Description
injection of Botulinum Toxin injection in lip muscles following cleft lip repair surgically.
Intervention Type
Procedure
Intervention Name(s)
Fisher technique
Intervention Description
The cleft lip will be treated surgically using the Fisher technique only.
Primary Outcome Measure Information:
Title
Change in cleft scar
Description
Vancouver Scar Scale: This scale focuses on four parameters:
scar height and thickness, pliability, vascularity, and pigmentation to generate a score ranging from 0 to 13 point
Time Frame
2 weeks, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change in scar width
Description
The scar width is to be measured at two certain points using digital caliper, one point is 1 mm above white line and the second point is 1 mm below nasal
Time Frame
2 weeks, 3 months, 6 months
Title
Change in lip height
Description
The lip height measurement will be done using digital caliper at cleft and non-cleft side.
Time Frame
2 weeks, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Minutes
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
With mild to severe cleft lip deformity requiring repair.
Neonates up to 1 year of age.
Patients with or without cleft palate.
Systemically healthy patients.
Patients follow postoperative instructions provided by their legal guardians.
Exclusion Criteria:
Patients with a syndromic type of cleft lip.
Patients suffering from relevant systemic and metabolic diseases.
Patients suffering from immunosuppressive diseases.
Patients suffering from neuromuscular disorders like Myasthenia Gravis.
Patients with special needs.
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair
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