Effectiveness of curcumin oral gel and triamcinolone acetonide gel in the treatment of Oral sub mucous fibrosis: A Randomised Control trail

The complete information about the study will be informed to the participants as mentioned in the participant information sheet (Appendix I). Signed informed consent will be obtained from all the participating subjects after explaining the complete procedure in their vernacular language (Appendix II). A modified case history performa will be used to collect data from the subjects (Appendix III).

Clinical test will be carried out for a total sample of 70 patients with clinical and functional diagnosis of Oral Submucous Fibrosis (stage1 and stage 2 according to as mentioned in heider SM8 classification and were classified into functional stages A, B, and C. In stage A, the MO >20 mm, stage B MO 11–19 mm, and stage C=<10. Patients will be randomly allocated into two groups of 35 patients each using simple random sampling technique.

GROUP A- CURCUMIN ORAL GEL

GROUP B- TRIAMCINOLONE ACETONIDE ORAL GEL.

During the first visit of the patient, all three parameters i.e Burning sensation, Inter- incisal length, tongue protrusion at the baseline will be measured along with modified case history performa.

Inter-incisal length (mouth opening)- will be measured with a vernier caliper from maxillary central incisor to mandibular central incisor tooth in millimetre9.

Burning sensation- will be recorded using VAS (Visual Analog Scale)10 scale (0-10) 0-1 will be no burning sensation ,2-4 will be mild burning sensation,5-7 will be tolerable burning sensation and 8-10 will be strongest burning sensation10.

Tongue protrusion- will be assessed and recorded by extension of tip of protruded tongue from mesial contact area of maxillary central incisors using divider and scale11.

 First Visit- After being clinically diagnosed with OSMF stage 1 & 2. The procedure will be explained to the patient in the vernacular language (annexure I) and consent will be taken (annexure II). After that all the three baseline values for required parameters will be recorded.

Instructions given for the process of topical application for both groups, pea sized amount of gel should be applied by massaging it on buccal mucosa. Patients were instructed to rinse mouth with water after 10–15 min and refrain to eat anything for about 30 minutes before and after the application of gel.

The patients will be advised to quit the areca nut/ betel nut chewing habit along with proper explanation and training of physiotherapy exercises (mouth opening)1.

Second Visit (14th day) and Third visit (30th day)- Patients will revisit the hospital, all the required parameters will be recorded and patients will be instructed to continue Oral gel application as well as motivated to abstain from areca nut/ betel nut chewing. They will also be advised to continue the physiotherapy exercises for mouth opening. The patients will be asked to report after 30st days and same protocol will be followed.**Fourth visit (45th day)-**Patients will visit the hospital, clinical examination, and all the required parameters will be recorded. Also patients will be advised to abstain from areca nut/ betel nut chewing habit.