Aphthous Stomatitis
Conditions
Keywords
aphthous stomatitis, night guard, inflammatory cytokine
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.
Interventions
DEVICEnight guard
60 days before and after intervention with the night guard
DEVICEplacebo night guard
60 days before and after intervention with the placebo night guard
Sponsors
University of Tokushima
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of developed aphthous stomatitis | through study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| days until healing | through study completion, an average of 1 year |
Countries
Japan
Outcome results
None listed