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RecruitingNot ApplicableNCT07436650

Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation

Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Clinical Trial

Sponsor

Ain Shams University

Enrollment

14 participants

Start Date

Jun 15, 2025

Study Type

INTERVENTIONAL

Conditions

Oral Mucositis

Summary

The goal of this clinical trial is to learn if high-level laser therapy can manage oral mucositis in pediatric patients undergoing hematopoietic bone marrow transplantation. The main question it aims to answer is : Is high-level laser therapy effective as a treatment for oral mucositis in pediatric hemopoietic stem cell transplant patients? Researchers will compare patients receiving basic oral care to see the effect on the WHO oral mucositis scale. Participants will be subjected to high level laser on lesion sites .

Eligibility

Max Age: 18 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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
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Interventions

DEVICEhigh power laser therapy

high power laser therapy once daily for four consecutive days with wavelength 660 to 970 nm, power 3.2 w, and duration of 230 seconds at 50% duty cycle

DRUGBasic oral care

patients will receive local methods: cholorohexidine mouthwash as well sodium bicarbonate mouthwash

Locations(1)

Oncology and Bone marrow transplant unit, Children's hospital, Ain Shams University

Cairo, Cairo Governorate, Egypt

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