Cleft Lip Clinical Trial
Official title:
Evaluation of Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair (Randomized Controlled Clinical Trial)
Verified date | October 2022 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 22 |
Est. completion date | October 1, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Minutes to 1 Year |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria Faculty of Dentistry | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Hams Hamed Abdelrahman |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 2 weeks, 3 months, 6 months | |
Secondary | Change in lip height | The lip height measurement will be done using digital caliper at cleft and non-cleft side. | 2 weeks, 3 months, 6 months |
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