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Completed

NCT Number: NCT05181943

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

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

Completed

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Key information

Conditions

Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Stomatognathic Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children diagnosed with mucositis and receiving chemotherapy

Exclusion criteria

  • diabetes
  • trismus

Treatment and study plan

Simpler diode laser

Device

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

Conventional symptomatic treatment

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 10, 2022
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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