se of Black Turmeric & Aloe-Vera as therapeutic agent for the management of Oral Submucous Fibrosis patients.

Phase 2

• Conditions: Health Condition 1: M728- Other fibroblastic disorders

• Registration Number: CTRI/2023/06/053755
• Lead Sponsor: Saveetha dental college and hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Both male & Female in equal ratio of total 400 patients will be selected. OSMF staging based on KERR et al (2011) and Passi et al (2017) criteria.

divided in 5 groups based on age.

1. Patients with Oral submucous fibrosis confirmed both clinically and histologically (Grade III)

2. Patients who are ready to quit the habit of Gutkha, Arecanut, Smoking, Tobacco and accepted for regular follow ups.

3. Patient with chief complaint of reduced mouth opening along with burning sensation and reduced tongue protrusion.

PRIMARY OBJECTIVES:

To evaluate the efficiency of Black turmeric and Aloe Vera Calcium carbonate nanoparticle in-situ gel for improving mouth opening in OSMF.

SECONDARY OBJECTIVES:

To evaluate the efficiency of Black turmeric and Aloe Vera Calcium carbonate nanoparticle in-situ gel for improving burning sensation in OSMF

To evaluate the efficiency of Black turmeric and Aloe Vera Calcium carbonate nanoparticle tongue protrusion in OSMF

Exclusion Criteria

1.Pregnant women and lactating mothers

2. Oral Submucous Fibrosis (OSMF) patients with early, mild and advanced condition.

3. Patients having concomitant disease with restricted mouth opening /burning sensation.

4. Patients with malignant lesions, systemic disorders like diabetes, thyroid, hypertension etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Clinical resolution of the lesion & comparison of Salivary LDH level in OSMF patients. <br/ ><br>2. Mouth opening as interincisal distance in mm. <br/ ><br>Timepoint: 4 weeks

Secondary Outcome Measures

Name	Time	Method
1 Burning sensation by visual analog scale VAS from 1 to 10 <br/ ><br>2 Tongue protrusion - mesioincisal angle of upper central incisor to the tip of tongue when maximally extended with mouth wide open. <br/ ><br>Timepoint: 4 weeks