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Clinical Trials/NCT05181943
NCT05181943CompletedNot Applicable

EFFECTIVNESS OF PHOTO BIO-MODULATION IN THE TREATMENT OF CHEMOTHERAPY INDUCED ORAL MUCOSITIS IN CHILDREN WITH ACUTE LEUKEMIA Randomized Controlled Clinical Trial

Alexandria University1 site in 1 country44 target enrollmentStarted: October 1, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
1
Primary Endpoint
Self-reported pain level

Study Overview

Brief Summary

The aim of the current study was to study the effect of diode laser in the treatment of chemotherapy induced mucositis in young patients suffering from leukemia

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • children diagnosed with mucositis and receiving chemotherapy

Exclusion Criteria

  • Not provided

Arms & Interventions

Laser irradiation (Test group)

Experimental

laser irradiation over lesion

Intervention: Simpler diode laser (Device)

Conventional treatment (Control group

Active Comparator

Intervention: Conventional symptomatic treatment (Drug)

Outcomes

Primary Outcomes

Self-reported pain level

Time Frame: up to 2 weeks

Participants were asked to report the degree of pain. This was assessed using the visual analogue scale (VAS) which ranges from zero (lowest score) to 10 (highest score). Higher scores indicate higher pain level.

Oral mucositis lesion size

Time Frame: up to 2 weeks

This was assessed using the World Health Organization oral mucositis lesion score Grade 0: no oral mucositis. Grade1: Presence of soreness and erythema. Grade 2: Presence of painful erythema and ulcerations that do not affect the patient solid food intake. Grade3: Confluent ulceration that affect the solid food intake and require liquid diet. Grade 4: The patient requires parenteral nutrition.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Farida Reayd

Instructor of Oral Medicine

Alexandria University

Study Sites (1)

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