Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: high power laser therapy, Basic oral care.
- Who it may be relevant to
- Registry conditions: Oral Mucositis. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Clinical Trial
Overview
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 .
Interventions
- 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 - Drug Basic oral care
patients will receive local methods: cholorohexidine mouthwash as well sodium bicarbonate mouthwash
Primary outcome measures
- Oral mucositis score [Time frame: at baseline (day 1), day 7, and day 11 from the start of treatment]
Secondary outcome measures (1)
- Pain score [Time frame: at baseline (day 1), day 7, and day 11 from the start of treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Oncology and Bone marrow transplant unit, Children's hospital, Ain Shams University — Cairo
Identifiers
NCT: NCT07436650 · FDASU-Rec IR/D052511