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Completed

NCT Number: NCT02890524

Tokushima Night Guard for Recurrent Aphthous Stomatitis

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.

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Key information

Conditions

Aphthous Stomatitis Mouth Diseases Stomatitis Stomatitis, Aphthous Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tada Dental Clinic, Kakogawa, Hyōgo, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

night guard

Device

60 days before and after intervention with the night guard

placebo night guard

Device

60 days before and after intervention with the placebo night guard

Primary outcomes

  1. number of developed aphthous stomatitis

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. days until healing

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

University of Tokushima

Other

Registry information

Official study title

Effects of a Night Guard on Aphthous Stomatitis

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2016
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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