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Tokushima Night Guard for Recurrent Aphthous Stomatitis

Not Applicable
Completed
Conditions
Aphthous Stomatitis
Interventions
Device: placebo night guard
Device: night guard
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.

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
Arm && Interventions
GroupInterventionDescription
Placebo night guardplacebo night guardPlacebo night guard made of EVA
Night guardnight guardthe night guard made of EVA
Primary Outcome Measures
NameTimeMethod
number of developed aphthous stomatitisthrough study completion, an average of 1 year
Secondary Outcome Measures
NameTimeMethod
days until healingthrough study completion, an average of 1 year

Trial Locations

Locations (2)

Tada Dental Clinic

🇯🇵

Kakogawa, Hyogo, Japan

Tokushima University Hospital

🇯🇵

Tokushima, Japan

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