EFFECTIVNESS OF PHOTO BIO-MODULATION IN THE TREATMENT OF CHEMOTHERAPY INDUCED ORAL MUCOSITIS IN CHILDREN WITH ACUTE LEUKEMIA Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Self-reported pain level
Study Overview
Brief Summary
The aim of the current study was to study the effect of diode laser in the treatment of chemotherapy induced mucositis in young patients suffering from leukemia
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •children diagnosed with mucositis and receiving chemotherapy
Exclusion Criteria
- Not provided
Arms & Interventions
Laser irradiation (Test group)
laser irradiation over lesion
Intervention: Simpler diode laser (Device)
Conventional treatment (Control group
Intervention: Conventional symptomatic treatment (Drug)
Outcomes
Primary Outcomes
Self-reported pain level
Time Frame: up to 2 weeks
Participants were asked to report the degree of pain. This was assessed using the visual analogue scale (VAS) which ranges from zero (lowest score) to 10 (highest score). Higher scores indicate higher pain level.
Oral mucositis lesion size
Time Frame: up to 2 weeks
This was assessed using the World Health Organization oral mucositis lesion score Grade 0: no oral mucositis. Grade1: Presence of soreness and erythema. Grade 2: Presence of painful erythema and ulcerations that do not affect the patient solid food intake. Grade3: Confluent ulceration that affect the solid food intake and require liquid diet. Grade 4: The patient requires parenteral nutrition.
Secondary Outcomes
No secondary outcomes reported
Investigators
Farida Reayd
Instructor of Oral Medicine
Alexandria University