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

Faculty of Dental Medicine for Girls

Status and phase: Completed; Phase 1

Conditions: Cleft Lip

Treatments: Drug: blue m gel; Device: biolase laser

Study type: Interventional

Funder types: Other

Identifiers

NCT06765837

OR SUR-106-1-C

Details and patient eligibility

About

the study was performed on secondary cleft lip scars

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 4 to 44 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Low level laser therapy

Experimental group

Treatment:

Device: biolase laser

active oxygen releasing gel

Experimental group

Treatment:

Drug: blue m gel

control group

No Intervention group