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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06765837

Acronym

LLLT

Enrollment

Registered

2025-01-09

Start date

2022-08-20

Completion date

2024-10-20

Last updated

2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip

Keywords

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

Brief summary

the study was performed on secondary cleft lip scars

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.

Interventions

DEVICEbiolase 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

DRUGblue m gel

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

4 Years to 44 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026