NCT06765837CompletedPhase 1
Effect of Low-Level Diode Laser Versus Active Oxygen Releasing Gel Application on Healing Outcome in Secondary Cleft Lip Correction
Faculty of Dental Medicine for Girls1 site in 1 country15 target enrollmentStarted: August 20, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Healing outcome of the wound is being measured by time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 44 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Low level laser therapy
Experimental
Intervention: biolase laser (Device)
active oxygen releasing gel
Experimental
Intervention: blue m gel (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Hager Abd almonem
master's student at Faculty of dental medicine for girls and dentist at ministry of health
Faculty of Dental Medicine for Girls
Study Sites (1)
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