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RecruitingNCT07436650Updated Mar 19, 2026

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

An interventional study of high power laser therapy and Basic oral care in Oral Mucositis, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jun 2025, registered Feb 2026).
  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
Up to 18 Years
Sex
All
01

Study 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 .

02

Conditions studied

  • Oral Mucositis

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Keywords

  • Oral Mucositis
  • High Level Laser Therapy
  • Hematopoietic Stem cell Transplant
03

In context

Stomatitis

306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.

This study's planned enrollment of 14 is below the median of 60 across 276 interventional studies indexed under Stomatitis.

Browse Stomatitis studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
14 participants (estimated)

Study arms

  • 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

  • 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

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

    Also known as: Laser biostimulation, Photobiomodulation therapy

  • DrugBasic oral care

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

    Also known as: conventional therapy

06

What researchers measure

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

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

Secondary outcomes

  1. 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

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

07

Study locations

1 of 1 sites recruiting
  • Oncology and Bone marrow transplant unit, Children's hospital, Ain Shams University
    Cairo, Cairo Governorate +2, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07436650
Responsible party
Asmaa Ayman Mohammed Gabr (Teaching Assistant, Ain Shams University) — Principal investigator
First posted
Feb 27, 2026
Start date
Jun 15, 2025
Primary completion
Aug 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Mar 19, 2026

Study contacts

Asmaa Ayman Gabr, Teaching Assistant
Contact
Asmaagabr@dent.asu.edu.eg
+2 01095692889

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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