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

NCT07436650 | Recruiting

• 1 other identifier: FDASU-Rec IR/D052511
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Oral Mucositis

Keywords

Oral Mucositis; High Level Laser Therapy; Hematopoietic Stem cell Transplant

Outcome Measures

Primary Outcomes (1)

• Oral mucositis score

  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

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

Secondary Outcomes (1)

• Pain score

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

Study Arms (2)

High power laser therapy group

EXPERIMENTAL

Pediatric bone marrow transplantation patients with oral mucositis will receive high-power laser therapy once daily for four consecutive days. The laser parameters will be a wavelength of 660 to 970 nm, of power 3.2 w, pulsed at 50% duty cycle, spot size of 1 cm2, for 230 sec, defocused mode.

Device: high power laser therapy

Basic oral care group

ACTIVE COMPARATOR

Pediatric bone marrow transplantation patients with oral mucositis will receive standard basic oral care. Local methods: mouth rinse chlorohexidine three times a day, sodium bicarbonate mouthwash.

Drug: Basic oral care

Interventions

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

Also known as: Laser biostimulation, Photobiomodulation therapy

High power laser therapy group

Basic oral care DRUG

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

Also known as: conventional therapy

Basic oral care group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Cairo Governorate, +2, Egypt

RECRUITING

MeSH Terms

Conditions

Stomatitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Asmaa Ayman Gabr, Teaching Assistant

CONTACT

+2 01095692889; Asmaagabr@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: June 15, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

EG (1)