Photodynamic Therapy by Curcumin VS Photo-bio-modulation Therapy of Oral Mucositis in Pedology Patient Undergoing Anti-Cancer Non-invasive Treatment

The study will be designed based on the Consolidated Standards of Reporting Trials (CONSORT) and conducted on approval from the Ethics Committee of the University. It will be a randomized controlled trial conducted among 90 pediatric patients of 3 years to 15 years age group. The inclusion criterion for the study will be i) patients in age group of 3 years to 15 years and ii) mucositis (categorized >1) based on the guidelines of WHO Toxicity Criteria. Pediatric patients having a malignant type of neoplasm and/or clinically evident oral microbial disease and/or with serious medical issues will be excluded from the study.

The oral mucositis will be diagnosed by a dentist available at the site of tertiary care hospital for chemotherapy. The potential participant will be referred to the research group for inclusion in the study based on the defined inclusion criterion. The procedure of research will be explained to the guardians of the participants. On acceptance, the guardians will be requested to sign the informed consent form.

The patients will considered as a new case for intervention on commencement of each chemo-therapy cycle. The patients will again added to a new randomized controlled trial if encountered an episode of oral mucositis.

Intervention for Photodynamic and Laser Therapy Prior to intervention of laser and photodynamic therapy the patients will be educated and instructed to maintain oral hygiene during cancer treatments. The instructions included brushing teeth with adequate amount of toothpaste and record it on follow-up chart. Later on inspection by the research team, if a patient is diagnosed with any carious lesion, retained root or gingival infection associated with dental plaque will be categorized as excluded from study. The procedure will be performed at beside for the patients admitted in the hospital; whereas outpatients will be seated on dental chairs of outpatient clinics.

An open controlled and blind, randomized clinical trial will be conducted with 45 patients, from 3 years to 15 years old, who will be divided into two groups. Group A will be submitted to photodynamic therapy (Curcumin and red laser, λ450 nm) with 142 J/cm2, 100mW. The number of points will be calculated based on the size of lesion (1 laser shot per cm2 of lesion). The intervention will be repeated daily until cure of the oral mucositis was attained. The clinical cure will be categorized as restoring the normal physiological functions such as chewing, swallowing and phonation without any symptoms of pain; additionally signs of tissue regeneration are evident.