Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair

Not Applicable

Completed

• Conditions: Cleft Lip
• Interventions: Other: Botulinum; Procedure: Fisher technique

• Registration Number: NCT05559281
• Lead Sponsor: Hams Hamed Abdelrahman

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-09-29
• Status Verified: 2022-10
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Last Update Submitted: 2022-10-02
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Botulinum	-
Group B	Fisher technique	-

Primary Outcome Measures

Name	Time	Method
Change in cleft scar	2 weeks, 3 months, 6 months	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

Name	Time	Method
Change in scar width	2 weeks, 3 months, 6 months	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	2 weeks, 3 months, 6 months	The lip height measurement will be done using digital caliper at cleft and non-cleft side.

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt