Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair
Evaluation of Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair (Randomized Controlled Clinical Trial)
1 other identifier
interventional
22
1 country
1
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
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 Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 25, 2022
CompletedFirst Posted
Study publicly available on registry
September 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 4, 2022
October 1, 2022
1.3 years
September 25, 2022
October 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
2 weeks, 3 months, 6 months
Secondary Outcomes (2)
Change in scar width
2 weeks, 3 months, 6 months
Change in lip height
2 weeks, 3 months, 6 months
Study Arms (2)
Group A
EXPERIMENTALGroup B
ACTIVE COMPARATORInterventions
injection of Botulinum Toxin injection in lip muscles following cleft lip repair surgically.
The cleft lip will be treated surgically using the Fisher technique only.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandria Faculty of Dentistry
Alexandria, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
September 25, 2022
First Posted
September 29, 2022
Study Start
July 1, 2021
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
October 4, 2022
Record last verified: 2022-10