Tokushima Night Guard for Recurrent Aphthous Stomatitis

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Brief Title

Tokushima Night Guard for Recurrent Aphthous Stomatitis

Official Title

Effects of a Night Guard on Aphthous Stomatitis

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 Type

Interventional


Primary Outcome

number of developed aphthous stomatitis

Secondary Outcome

 days until healing

Condition

Aphthous Stomatitis

Intervention

night guard

Study Arms / Comparison Groups

 Night guard
Description:  the night guard made of EVA

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

July 2014

Completion Date

March 2018

Primary Completion Date

March 2018

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Yasusei Kudo, DDS, PhD, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT02890524

Organization ID

Tokushima #2053


Responsible Party

Principal Investigator

Study Sponsor

University of Tokushima


Study Sponsor

Yasusei Kudo, DDS, PhD, Principal Investigator, Tokushima University


Verification Date

April 2019