Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT05181943

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Mucositis	Device: Simpler diode laser Drug: Conventional symptomatic treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Nov 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laser irradiation (Test group) laser irradiation over lesion	Device: Simpler diode laser Non-contacting irradiation for 30 seconds on three intraoral sites repeated four times
Active Comparator: Conventional treatment (Control group	Drug: Conventional symptomatic treatment Conventional treatment using oracure, BBC spray, miconaz three times daily

Arm

Intervention/Treatment

Experimental: Laser irradiation (Test group)

laser irradiation over lesion

Device: Simpler diode laser

Non-contacting irradiation for 30 seconds on three intraoral sites repeated four times

Active Comparator: Conventional treatment (Control group

Drug: Conventional symptomatic treatment

Conventional treatment using oracure, BBC spray, miconaz three times daily

Outcome Measures

Primary Outcome Measures

Self-reported pain level [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

children diagnosed with mucositis and receiving chemotherapy

Exclusion Criteria:

diabetes
trismus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Alexandria University	Alexandria		Egypt	21527

Sponsors and Collaborators

Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Farida Reayd, Instructor of Oral Medicine, Alexandria University

ClinicalTrials.gov Identifier:

NCT05181943

Other Study ID Numbers:

332021

First Posted:

Jan 10, 2022

Last Update Posted:

Jan 10, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Farida Reayd, Instructor of Oral Medicine, Alexandria University

mucositis - leukemia - chemotherapy

Additional relevant MeSH terms:

Mucositis

Study Results

No Results Posted as of Jan 10, 2022