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

Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181943
• Other study ID #: 332021
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• children diagnosed with mucositis and receiving chemotherapy

Exclusion Criteria:

• diabetes
• trismus

Related Conditions & MeSH terms

• Mucositis

Intervention

Device:
• Simpler diode laser
Non-contacting irradiation for 30 seconds on three intraoral sites repeated four times

Drug:
• Conventional symptomatic treatment
Conventional treatment using oracure, BBC spray, miconaz three times daily

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported pain level	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.	up to 2 weeks
Primary	Oral mucositis lesion size	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.	up to 2 weeks