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

Assessment of effect of Black Turmeric and aloe vera loaded calcium carbonate nanoparticle laden insitu gel in management of oral submucous fibrosis. A randomized clinical trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053755

Enrollment

100

Registered

2023-06-12

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M728- Other fibroblastic disorders

Interventions

None listed

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. Clinical resolution of the lesion & comparison of Salivary LDH level in OSMF patients. 2. Mouth opening as interincisal distance in mm. Timepoint: 4 weeks	—

Secondary

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

Countries

India

Contacts

Public ContactDr TN Uma Maheswari

Saveetha Dental College and Hospital

umamaheswaritn@saveetha.com

Outcome results