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

Not Applicable

Completed

• Conditions: Mucositis
• Interventions: Device: Simpler diode laser; Drug: Conventional symptomatic treatment

• Registration Number: NCT05181943
• Lead Sponsor: Alexandria University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2021-11-01
• Status Verified: 2021-12
• Study Completion: 2021-12-01
• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Last Update Submitted: 2021-12-20
• Study First Posted: 2022-01-10
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• children diagnosed with mucositis and receiving chemotherapy

Exclusion Criteria

• diabetes
• trismus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser irradiation (Test group)	Simpler diode laser	laser irradiation over lesion
Conventional treatment (Control group	Conventional symptomatic treatment	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt