Tokushima Night Guard for Recurrent Aphthous Stomatitis

NCT ID: NCT02890524

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Aphthous Stomatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Night guard

the night guard made of EVA

Group Type EXPERIMENTAL

night guard

Intervention Type DEVICE

60 days before and after intervention with the night guard

Placebo night guard

Placebo night guard made of EVA

Group Type PLACEBO_COMPARATOR

placebo night guard

Intervention Type DEVICE

60 days before and after intervention with the placebo night guard

Interventions

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night guard

60 days before and after intervention with the night guard

Intervention Type DEVICE

placebo night guard

60 days before and after intervention with the placebo night guard

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tokushima

OTHER

Sponsor Role lead

Responsible Party

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Yasusei Kudo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasusei Kudo, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Tokushima University

Locations

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Tada Dental Clinic

Kakogawa, Hyōgo, Japan

Site Status

Tokushima University Hospital

Tokushima, , Japan

Site Status

Countries

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Japan

Other Identifiers

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Tokushima #2053

Identifier Type: -

Identifier Source: org_study_id

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