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.
Group B (control group) will be submitted to low level (LL) laser therapy (λ660 nm) with
1J energy per point at 100mW power output for 10 seconds on daily basis until the lesion
was clinically cured. The light will be applied perpendicular to the lesion on a
continuous mode. The number of points will calculated similarly as mentioned for patients
included in Group A.
Oral Mucositis Evaluation After inter-examiner reliability test, the patients will be
evaluated by the by the research group. The scale proposed and accepted by World Health
Organization (WHO) will be used to categorize the changes in oral mucositis condition
evaluated over time in four different categories: i) Category 0 = Absence of change in
condition; ii) Category I = Persistence of erythematous condition and failure to have
solid food; iii) Category II = Persistence of erythematous condition with solid dietary
food intake iv) Category III: Presence of painful erythematous lesion with liquids as a
dietary intake; and Category IV: patient with special mode for dietary intake (parenteral
or enteral).
For evaluating the intensity of paint and variation in function, the ChIME scale will be
used. The data will be recorded on special designed forms. The patients will be divided
randomly and later treated with lasers and photodynamic therapy.