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

NCT06765837 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: OR SUR-106-1-C
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

the study was performed on secondary cleft lip scars

Conditions

Cleft Lip

Keywords

Low level laser; cleft lip; scars; active oxygen releasing

Outcome Measures

Primary Outcomes (1)

• Healing outcome of the wound is being measured by time

  measurements done by ultrasonography repeatedly , before and 1 week after surgery , 3 months after and 6 months after

  6 months follow up

Study Arms (3)

Low level laser therapy

EXPERIMENTAL

Device: biolase laser

active oxygen releasing gel

EXPERIMENTAL

Drug: blue m gel

control group

NO INTERVENTION

Interventions

biolase laser DEVICE

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

Low level laser therapy

blue m gel DRUG

active oxygen releasing gel was used after the secondary cleft lip repair surgery

active oxygen releasing gel

Eligibility Criteria

• Age: 4 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• primary cleft lip repair was done
• secondary lip repair with or without nose correction is indicated
• the patient didn't undergo any surgeries procedures in the last 6 months

You may not qualify if:

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

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Hager Abdelmonem Abdelaziz

Cairo, 12345, Egypt

Location

MeSH Terms

Conditions

Cleft Lip; Cicatrix

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

Study Officials

• Mohsena Ahmed

  lecturer of orthodontoics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master's student at Faculty of dental medicine for girls and dentist at ministry of health

Model Details: 3 groups underwent secondary repair cleft lip surgeries the first group subjected to low level laser after surgery the second group applied active oxygen releasing topical gel the third was a control group

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 9, 2025
• Study Start: August 20, 2022
• Primary Completion: April 20, 2024
• Study Completion: October 20, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

EG (1)