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OpenTrials
Completed

NCT Number: NCT06765837

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

the study was performed on secondary cleft lip scars

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Key information

Conditions

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

Age range

4 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hager Abdelmonem Abdelaziz

Cairo, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

blue m gel

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Faculty of Dental Medicine for Girls

Other Gov

Registry information

Official study title

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

Acronym: LLLT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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