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NCT Number: NCT07436650

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

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 .

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Key information

Conditions

Oral Mucositis Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Cairo Governorate, +2, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High power Laser therapy

Device

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

Other names: Laser biostimulation, Photobiomodulation therapy

Basic oral care

Drug

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

Other names: conventional therapy

Primary outcomes

  1. Oral mucositis score

    Time frame: at baseline (day 1), day 7, and day 11 from the start of treatment

    World Health Organization (WHO) scale of oral mucositis will be used to describe the lesions at baseline, day 7 and day 11, lesions are given grades from 1 to 4, with 4 being a worse outcome

Secondary outcomes

  1. Pain score

    Time frame: at baseline (day 1), day 7, and day 11 from the start of treatment

    Pain visual analogue scale will be used to measure pain level, where the patient will be given a diagram representing pain levels from 1 to 10, 10 being the highest level of pain

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa Ayman Gabr, Teaching Assistant

CONTACT

[email protected]

+2 01095692889

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Feb 27, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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