Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair

October 2, 2022 updated by: Hams Hamed Abdelrahman

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cleft scar
Time Frame: 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
2 weeks, 3 months, 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2021

Primary Completion (ACTUAL)

October 1, 2022

Study Completion (ACTUAL)

October 1, 2022

Study Registration Dates

First Submitted

September 25, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (ACTUAL)

September 29, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 2, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Botulinum_2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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