Efficacy of antioxidants in the management of Oral submucous fibrosis

Completed

• Conditions: 50 Oral Submucous Fibrosis Patients

• Registration Number: CTRI/2018/04/013285
• Lead Sponsor: Narayana Dental College and Hospital

Brief Summary

Background and objectives

The review of current literature showed that combined use of antioxidants in the treatment of oral submucous fibrosis was not adequately explored and research in this area is very limited. Hence the present randomized clinical trail was carried out to evaluate the efficacy of Lycopene versus Lycopene and circumin in the management of Oral submucous fibrosis.

Trail was completed

Randomized Clinical Trial of lycopene versus Curcumin with lycopene in management of Oral Submucous Fibrosis with end points being improvement in Interincisal Mouth opening, Cheek Flexibility and Reduction in Burning Sensation among patients with combined therapy by the time  trial was Completed.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-11
• Study Completion: 2018-01-03
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

25 Oral Submucous Fibrosis patients to be put on Systemic lycopene therapy alone 25 Oral Submucous Fibrosis patients to be put on a combination of Lycopene and Curcumin.

Exclusion Criteria

Hypersensitivity to Curcumin and /or lycopene Patients with Gall Stones and other Gastrointestinal disorders Patients with Fibrotic lesions other than Oral Sub Mucous Fibrosis Patients receiving any other medications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief from Burning Sensation	at end of first month and at the end of three months after starting the therapy
Improved Interincisal Mouth Opening	at end of first month and at the end of three months after starting the therapy
Cheek Mucosa Flexibility Improvement	at end of first month and at the end of three months after starting the therapy

Secondary Outcome Measures

Name	Time	Method
Relief from Burning Sensation

Trial Locations

Locations (1)

Narayana Dental College and Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

Narayana Dental College and Hospital

🇮🇳Nellore, ANDHRA PRADESH, India

Kannan Natarajan

Principal investigator

9490471078

dentkan1@gmail.com