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

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 .

Study Overview

• Status: Recruiting
• Conditions: Oral Mucositis
• Intervention / Treatment: Device: high power laser therapy; Drug: Basic oral care

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asmaa Ayman Gabr, Teaching Assistant; Phone Number: +2 01095692889; Email: Asmaagabr@dent.asu.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, +2
      • Recruiting
      • Oncology and Bone marrow transplant unit, Children's hospital, Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High power laser therapy group; 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; 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: Photobiomodulation therapy; Laser biostimulation
Active Comparator: Basic oral care group; 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; patients will receive local methods: cholorohexidine mouthwash as well sodium bicarbonate mouthwash; Other Names: conventional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	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	at baseline (day 1), day 7, and day 11 from the start of treatment

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Oral Mucositis; High Level Laser Therapy; Hematopoietic Stem cell Transplant
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatitis; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: FDASU-Rec IR/D052511

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No