The purpose of the study is to determine whether the formulations of curcumin will effect the clinical signs and symptoms and histopathological features in patients with clinical stage 2 oral submucous fibrosis (OSMF).
200 clinical stage 2 OSMF patients selected randomly by simple random technique with clinically \& histopathologically confirmed diagnosis are divided into 4 groups with 50 patients each. In Group 1 patients are given 10% of curcumin mucoadhesive gel and are instructed to use it topically twice daily making it a daily dose of 1gm. In Group 2 patients are given 500mg of curcumin capsules and are instructed to take 2 capsules twice daily making a daily dose of 1gm. In Group 3 patients will be given 5% of curcumin mucoadhesive gel and will be instructed to use it topically twice daily \& 250mg of curcumin capsules to be taken twice daily making it a daily dose of 1gm. Group 4 is considered as control group and provided with formulations without the active drug. The mean scores of 4 groups will be statistically tested using Anova technique. The differences in clinical parameters at 15 days, 1 month, 3 months \& clinical \& histopathological paramerters at 6 months will be compared between groups 1, 2, 3 \& 4 by using students 't' test \& correlation is also used for knowing the association of variables. For all tests, a 'p' value of 0.05 or less will be utilized for statistical significance. Other non parametric tests can also be applied where ever necessary for data analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Group 1 10%of mucoadhesive gel for topical application two times per day.
Group 2 curcumin 500 mg capsules for oral intake two times per day
Group 3 5% curcumin mucoadhesive gel topical application two times per day + curcumin 250 mg capsules for oral intake two times per day
HKE'S S.N Institute of dental sciences & research center
Kalaburagi, Karnataka, India
RECRUITINGBurning sensation and pain
Visual Analogue Scale
Time frame: 6 months for each patient
Interincisal distance, tongue protrusion and cheek flexibility
All these will be measured in mm at designated time intervals using digital vernier calliper.
Time frame: 6 months for each patient
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Group 4 placebo capsules for oral intake two times per day