Comparison Between Low Level Laser Therapy and Active Oxygen Releasing Gel on Wound Healing Cleft Lip Patients (LLLT)

January 3, 2025 updated by: Hager Abd almonem, Faculty of Dental Medicine for Girls

Effect of Low-Level Diode Laser Versus Active Oxygen Releasing Gel Application on Healing Outcome in Secondary Cleft Lip Correction

the study was performed on secondary cleft lip scars

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

the study aimed at comparing and Evaluation the effect of low-level diode laser and the effect of Active Oxygen releasing gel O3 (Blue-m gel) topical application on healing outcome in secondary cleft lip correction.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

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
      • Cairo, Egypt, 12345
        • Hager Abdelmonem Abdelaziz

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age: can be done in any time after six months from the previous surgery if it severely disfiguring or in the preschool stage for children the time of surgery should be based on the severity of deformities
  2. primary cleft lip repair was done
  3. secondary lip repair with or without nose correction is indicated
  4. the patient didn't undergo any surgeries procedures in the last 6 months

Exclusion Criteria:

  1. previously subjected to secondary lip repair surgery.
  2. syndromic cleft lip patient.
  3. patient reporting abnormal reaction or scar healing in the previous surgery
  4. smoking patients

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Experimental: Low level laser therapy
Device: biolase laser
after secondary cleft lip surgery to improve wound healing and prevent scar formation laser was used with group I and Gel was applied to Group II
Experimental: active oxygen releasing gel
Drug: blue m gel
active oxygen releasing gel was used after the secondary cleft lip repair surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing outcome of the wound is being measured by time
Time Frame: 6 months follow up
measurements done by ultrasonography repeatedly , before and 1 week after surgery , 3 months after and 6 months after
6 months follow up

Collaborators and Investigators

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

Sponsor

Faculty of Dental Medicine for Girls

Investigators

  • Study Director: Mohsena Ahmed, lecturer of orthodontoics

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)

August 20, 2022

Primary Completion (Actual)

April 20, 2024

Study Completion (Actual)

October 20, 2024

Study Registration Dates

First Submitted

December 29, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OR SUR-106-1-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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