Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair

Cleft Lip Clinical Trial

Official title:

Evaluation of Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair (Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05559281
• Other study ID #: Botulinum_2020
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cleft Lip

Intervention

Other:
• Botulinum
injection of Botulinum Toxin injection in lip muscles following cleft lip repair surgically.

Procedure:
• Fisher technique
The cleft lip will be treated surgically using the Fisher technique only.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

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