Effects of a Night Guard on Aphthous Stomatitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Tokushima
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- number of developed aphthous stomatitis
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- All
- Accepts 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
Arms & Interventions
Night guard
the night guard made of EVA
Intervention: night guard (Device)
Placebo night guard
Placebo night guard made of EVA
Intervention: placebo night guard (Device)
Outcomes
Primary Outcomes
number of developed aphthous stomatitis
Time Frame: through study completion, an average of 1 year
Secondary Outcomes
- days until healing(through study completion, an average of 1 year)
Investigators
Yasusei Kudo
Associate Professor
University of Tokushima