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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorAin Shams University

About this 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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Basic oral care

    Drug

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

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: High power laser therapy groupExperimental treatment 1 intervention
Group B: Basic oral care groupActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.