Tokushima Night Guard for Recurrent Aphthous Stomatitis

University of Tokushima

Status: Completed

Conditions: Aphthous Stomatitis

Treatments: Device: placebo night guard; Device: night guard

Study type: Interventional

Funder types: Other

Identifiers

NCT02890524

Tokushima #2053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Night guard

Experimental group

Description:

the night guard made of EVA

Treatment:

Device: night guard

Placebo night guard

Placebo Comparator group

Description:

Placebo night guard made of EVA

Treatment:

Device: placebo night guard