NCT02890524

Tokushima Night Guard for Recurrent Aphthous Stomatitis

Effects of a Night Guard on Aphthous Stomatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Tokushima · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Aphthous Stomatitis

Interventions

Type	Name	Description
DEVICE	night guard	60 days before and after intervention with the night guard
DEVICE	placebo night guard	60 days before and after intervention with the placebo night guard

Timeline

• Start date: 2014-07-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2016-09-07
• Last updated: 2019-04-17

Locations

2 sites across 1 country: Japan