Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair

• Sponsor: Hams Hamed Abdelrahman (Other)
• Overall Status: Completed
• CT.gov ID: NCT05559281
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 15
• Patients Per Site Per Month: 1.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cleft Lip	Other: Botulinum; Procedure: Fisher technique	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair (Randomized Controlled Clinical Trial)
• Actual Study Start Date: Jul 1, 2021
• Actual Primary Completion Date: Oct 1, 2022
• Actual Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A	Other: Botulinum; injection of Botulinum Toxin injection in lip muscles following cleft lip repair surgically.
Active Comparator: Group B	Procedure: Fisher technique; The cleft lip will be treated surgically using the Fisher technique only.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Minutes to 1 Year
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Faculty of Dentistry	Alexandria		Egypt

Sponsors and Collaborators

• Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
• ClinicalTrials.gov Identifier: NCT05559281
• Other Study ID Numbers: Botulinum_2020
• First Posted: Sep 29, 2022
• Last Update Posted: Oct 4, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cleft Lip

Study Results

No Results Posted as of Oct 4, 2022