Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy.

NCT ID: NCT07137234

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-15

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Unilateral Cleft Lip

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Modified Millard rotation advancement flap technique

Intervention Type PROCEDURE

the cleft is repaired by surgical intervention

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

Group Type EXPERIMENTAL

Modified Millard rotation advancement flap technique

Intervention Type PROCEDURE

the cleft is repaired by surgical intervention

botulinum toxin injection (BTX A) before surgical intervention

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Modified Millard rotation advancement flap technique

the cleft is repaired by surgical intervention

Intervention Type PROCEDURE

botulinum toxin injection (BTX A) before surgical intervention

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. patients with mild to severe unilateral cleft lip requiring repair
2. free from any systemic disease

Exclusion Criteria

1- patients with syndromic type of cleft lip 2- patients with systemic disease
Minimum Eligible Age

10 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Basel Saeed Sayed Ahmed Shamaa

Clinical Demonstrator at oral and maxillofacial surgery department, Faculty of dentistry, Mansoura University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Basel Saeed Shamaa, Master's

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura University

Al Mansurah, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M0101025OS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.