Clinical Trial: Topical Application of Curcumin Orabase in Oral Submucous Fibrosis (OSMF)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Topical Application of Curcumin Incorporated in Orabase in OSMF Patients

Brief Summary: Curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived from the rhizome of the East Indian plant Curcuma longa. Curcuma longais a member of the Zingiberacae (ginger) family of botanicals and is a perennial plant that is native to Southeast Asia. Turmeric contains a class of compounds known as the curcuminoids, comprised of curcumin, demethoxy curcumin and bisdemethoxycurcumin.

Detailed Summary:

Anti-inflammatory mechanisms implicated in the anticarcinogenic potential of curcumin include: (1) inhibition of NF-κB and COX-2 (increased levels of COX-2 are associated with many cancer types); (2)inhibition of arachidonic acid metabolism via lipoxygenase and scavenging of free radicals generated in this pathway; (3) decreased expression of inflammatory cytokines IL-1b, IL-6, and TNF-a, resulting in growth inhibition of cancer cell lines; and (4) down-regulation of enzymes, such as protein kinase C, that mediate inflammation and tumor-cell proliferation.

Curcumin's potent anti-oxidant and free-radical quenching properties play an important role in the inhibitory effects of the compound on the initial stages of carcinogenesis. Antioxidants are implicated in the pathogenesis of OSMF and hence this preparation may be helpful in resolution of this lesion.


Sponsor: SVS Institute of Dental Sciences

Current Primary Outcome: Reduction in OSMF lesion [ Time Frame: up to 6 months ]

The number of bands and the consistency of the lesion will be evaluated at designated time intervals using appropriate indices.


Original Primary Outcome: Same as current

Current Secondary Outcome: Jaw Opening [ Time Frame: up to 6 months ]

Jaw opening in mm will be measured at designated time intervals using an appropriate instrument.


Original Secondary Outcome: Same as current

Information By: SVS Institute of Dental Sciences

Dates:
Date Received: December 29, 2015
Date Started: December 2013
Date Completion: February 2016
Last Updated: January 4, 2016
Last Verified: January 2016