Oral Submucous Fibrosis
Conditions
Keywords
Oral submucous fibrosis, curcumin, potentially malignant disease
Brief summary
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).
Detailed description
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.
Interventions
DRUG10% Curcumin mucoadhesive gel
Group 1 10%of mucoadhesive gel for topical application two times per day.
DRUGCurcumin capsules 500mg
Group 2 curcumin 500 mg capsules for oral intake two times per day
DRUG5% curcumin mucoadhesive gel + Curcumin capsules 250 mg
Group 3 5% curcumin mucoadhesive gel topical application two times per day + curcumin 250 mg capsules for oral intake two times per day
DRUGPlacebo capsule
Group 4 placebo capsules for oral intake two times per day
Sponsors
H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
single blinded
Intervention model description
four groups, each group with different formulations.
Eligibility
Sex/Gender
ALL
Age
14 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 200 clinical stage 2 OSMF patients
Exclusion criteria
* Clinical stage 1 & 3 OSMF patients, oromucosal disorders with clinical features same as OSMF, patients who are under treatment, clinically diagnosed cases not ready for incisional biopsy, patients suffering from medically compromised conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Burning sensation and pain | 6 months for each patient | Visual Analogue Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interincisal distance, tongue protrusion and cheek flexibility | 6 months for each patient | All these will be measured in mm at designated time intervals using digital vernier calliper. |
Countries
India
Contacts
Primary ContactJayashree Mudda, MDS
Outcome results
None listed