Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy.

NCT07137234 | Recruiting DMC

• 1 other identifier: M0101025OS
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of the study will be directed to evaluate clinically the effect of botulinum toxin type A injection on reducing the scar following cleft lip surgical repair.

Conditions

Unilateral Cleft Lip

Keywords

botulinum toxin; cleft lip; scar

Outcome Measures

Primary Outcomes (1)

• Scar width

  Scar width will be measured by independent examiners at two at two certain points using caliper: point 1 (Bottom) :above the white roll. point 2 (Top): below the nasal sill.

  3 and 6 months follow up

Secondary Outcomes (1)

• Vancouver scar scale

  3 and 6 months

Study Arms (2)

Group I : 16 patient with unilateral cleft lip treated with surgical procedure alone

EXPERIMENTAL

Procedure: Modified Millard rotation advancement flap technique

Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery

EXPERIMENTAL

Procedure: Modified Millard rotation advancement flap technique; Drug: botulinum toxin injection (BTX A) before surgical intervention

Interventions

Modified Millard rotation advancement flap technique PROCEDURE

the cleft is repaired by surgical intervention

Group I : 16 patient with unilateral cleft lip treated with surgical procedure alone; Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery

botulinum toxin injection (BTX A) before surgical intervention DRUG

the patient will receive Botulinum toxin type A followed by surgical closure of cleft lip

Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery

Eligibility Criteria

• Age: 10 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with mild to severe unilateral cleft lip requiring repair
• free from any systemic disease
• with or without cleft palate

You may not qualify if:

• patients with syndromic type of cleft lip
• patients with systemic disease

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Cleft Lip; Cicatrix

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Basel Saeed Shamaa, Master's

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basel Saeed Shamaa, Master's

CONTACT

+201067705286; baselshamaa@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Demonstrator at oral and maxillofacial surgery department, Faculty of dentistry, Mansoura University

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: August 22, 2025
• Study Start: March 15, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: starting 1 year after publication

Locations

EG (1)