Tokushima Night Guard for Recurrent Aphthous Stomatitis

Not Applicable

Completed

• Conditions: Aphthous Stomatitis

• Registration Number: NCT02890524
• Lead Sponsor: University of Tokushima

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 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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2016-08-21
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients suffered from recurrent aphthous stomatitis at least once a month

Exclusion Criteria

• People do not have a experience of recurrent aphthous stomatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
number of developed aphthous stomatitis	through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
days until healing	through study completion, an average of 1 year

Trial Locations

Locations (2)

Tada Dental Clinic; 🇯🇵 Kakogawa, Hyogo, Japan

Tokushima University Hospital; 🇯🇵 Tokushima, Japan