Clinical Trial: Tokushima Night Guard for Recurrent Aphthous Stomatitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effects of a Night Guard on Aphthous Stomatitis

Brief Summary: The investigators will investigate whether the night guard can suppress the development of recurrent aphthous stomatitis (RAS). The investigators will record the patients' oral condition for 60 days before and after intervention with the night guard made of Ethylene-Vinyl Acetate copolymer (EVA). The patients' saliva will be analyzed for measurement of inflammatory cytokines or oxidative stress.

Detailed Summary: The study involved 20 patients (8 male and 12 female) with RAS. These patients suffered from RAS at least once a month. The investigators will record their oral condition for 60 days before and after intervention with the night guard made of EVA. Their saliva will be analyzed for further studies including measurement of inflammatory cytokines or oxidative stress.
Sponsor: University of Tokushima

Current Primary Outcome: number of developed aphthous stomatitis [ Time Frame: through study completion, an average of 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: days until healing [ Time Frame: through study completion, an average of 1 year ]

Original Secondary Outcome: Same as current

Information By: University of Tokushima

Dates:
Date Received: August 21, 2016
Date Started: July 2014
Date Completion: March 2018
Last Updated: May 1, 2017
Last Verified: May 2017