High-level laser therapy for oral mucositis in children receiving hematopoietic stem cell transplant
Official title: Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Clinical Trial
Run by Ain Shams University · NCT07436650 · Data updated 2026-11-12
This trial tests whether high-level laser therapy can reduce the pain and severity of oral mucositis in children undergoing hematopoietic stem cell (bone marrow) transplantation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 14 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Status | Recruiting |
| Started | June 15, 2025 |
| Main results expected | August 2030 |
| Study ends | December 2030 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT07436650 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children under 18 undergoing bone marrow/hematopoietic stem cell transplant who develop WHO grade II or higher oral mucositis and can attend four consecutive treatment days plus follow-up visits.
✕Probably not a fit
Patients with prior photobiomodulation, mouth opening less than 2 cm, dysplastic oral lesions, prior head/neck radiation, or those unable to consent/participate are unlikely to be eligible or benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls pediatric patients under 18 who develop WHO grade II or higher oral mucositis during hematopoietic stem cell transplantation. Participants receive high-level laser therapy applied to lesion sites for four consecutive days and are compared with patients receiving basic oral care, with outcomes recorded on the WHO oral mucositis scale. Follow-up visits occur at 7 and 11 days after enrolment to measure changes in severity and healing. Key exclusions include prior photobiomodulation, limited mouth opening, dysplastic oral lesions, and prior head and neck radiotherapy.
Why it matters
Potential benefit: If effective, the therapy could shorten the duration and reduce the severity and pain of oral mucositis, improving eating comfort and reducing supportive care needs.
How similar studies have gone: Low-level laser (photobiomodulation) has shown benefit for oral mucositis in multiple studies, but use of high-power laser specifically in pediatric HSCT patients is less well studied and evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where it's running
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Oncology and Bone marrow transplant unit, Children's hospital, Ain Shams University
Cairo, Cairo Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Asmaa Ayman Gabr, Teaching Assistant
- Email: Asmaagabr@dent.asu.edu.eg
- Phone: +2 01095692889
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.