Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10%Curcumin mucoadhesive gel | Active Comparator | Drug: Curcumin arm Curcumin10% mucoadhesive gel Group 1 patients: Drug : 10% curcumin mucoadhesive gel usage : Topical application Frequency : Twice daily Duration : 6 months |
|
| Curcumin capsules 500mg | Active Comparator | Group 2 patients: Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months |
|
| 5% Curcumin gel+Curcumin capsules 250mg | Active Comparator | Group 3 patients: Drug: 5% Curcumin mucoadhesive gel & Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months |
|
| Placebo capsules | Placebo Comparator | Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% Curcumin mucoadhesive gel | Drug | Group 1 10%of mucoadhesive gel for topical application two times per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Burning sensation and pain | Visual Analogue Scale | 6 months for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Interincisal distance, tongue protrusion and cheek flexibility | All these will be measured in mm at designated time intervals using digital vernier calliper. | 6 months for each patient |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jayashree Mudda, MDS | Contact | +919741804012 | jayashreemudda@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Syeda Arshiya Ara, MDS | HKE'S S.N Institute of dental sciences & research center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HKE'S S.N Institute of dental sciences & research center | Recruiting | Kalaburagi | Karnataka | 585102 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26604488 | Background | Hazarey VK, Sakrikar AR, Ganvir SM. Efficacy of curcumin in the treatment for oral submucous fibrosis - A randomized clinical trial. J Oral Maxillofac Pathol. 2015 May-Aug;19(2):145-52. doi: 10.4103/0973-029X.164524. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009914 | Oral Submucous Fibrosis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
four groups, each group with different formulations.
Not provided
Not provided
single blinded
| Curcumin capsules 500mg | Drug | Group 2 curcumin 500 mg capsules for oral intake two times per day |
|
|
| 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg | Drug | Group 3 5% curcumin mucoadhesive gel topical application two times per day + curcumin 250 mg capsules for oral intake two times per day |
|
|
| Placebo capsule | Drug | Group 4 placebo capsules for oral intake two times per day |
|
|
| D009930 |
| Organic Chemicals |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |