Actively Recruiting
Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Clinical Trial
Led by Ain Shams University · Updated on 2026-03-19
14
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates whether high-level laser therapy can help manage oral mucositis in children undergoing hematopoietic stem cell transplantation. The study aims to find out if this laser treatment is effective in reducing oral mucositis severity compared to basic oral care. The focus is on pediatric patients experiencing oral mucositis at grade II or higher on the WHO scale. Participants are randomly assigned to one of two groups. One group receives high-power laser therapy once daily for four days, using a laser with specific settings including a wavelength of 660 to 970 nm and power of 3.2 watts for 230 seconds in pulsed mode. The other group receives standard basic oral care, including mouth rinses with chlorhexidine and sodium bicarbonate three times daily. Treatments are administered during the oral mucositis phase. Throughout the study, participants will be evaluated at baseline, day 7, and day 11 for oral mucositis severity using the WHO scale and pain levels. The study tracks these outcomes to assess the impact of the treatments. Children will need to return for follow-up visits on days 7 and 11 after starting treatment. The study is sponsored by Ain Shams University and will run until December 2030.
CONDITIONS
Brief Title
Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children under the age of 18 years undergoing bone marrow transplantation during the phase of oral mucositis.
- Oral mucositis starting from grade II on the WHO scale for OM.
- Willingness to undergo treatment for four consecutive days and to return for evaluation 7 and 11 days after enrolment.
You will not qualify if you...
- Previous treatment with photobiomodulation for oral mucositis.
- Limited mouth opening less than 2 cm.
- Presence of dysplastic oral lesions.
- Radiotherapy in the head and neck area.
- Vulnerable groups of patients or decision-impaired individuals as prisoners, handicapped and mentally retarded individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days
Participants receive either high-power laser therapy once daily for four consecutive days or basic oral care with mouth rinses.
4 daily visits (in-person)
Duration - 7 days
Participants return for evaluation visits to assess oral mucositis and pain scores following treatment.
2 visits (in-person) on days 7 and 11 after treatment start
Trial Site Locations
Total: 1 location
1
Oncology and Bone marrow transplant unit, Children's hospital, Ain Shams University
Cairo, Cairo Governorate, Egypt, +2
Actively Recruiting
Research Team
A
Asmaa Ayman Gabr, Teaching Assistant
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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