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Trial record 2 of 29 for:    "Aphthous stomatitis"

Tokushima Night Guard for Recurrent Aphthous Stomatitis

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ClinicalTrials.gov Identifier: NCT02890524
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Yasusei Kudo, 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.

Condition or disease Intervention/treatment Phase
Aphthous Stomatitis Device: night guard Device: placebo night guard Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effects of a Night Guard on Aphthous Stomatitis
Study Start Date : July 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Canker Sores

Arm Intervention/treatment
Experimental: Night guard
the night guard made of EVA
Device: night guard
60 days before and after intervention with the night guard

Placebo Comparator: Placebo night guard
Placebo night guard made of EVA
Device: placebo night guard
60 days before and after intervention with the placebo night guard




Primary Outcome Measures :
  1. number of developed aphthous stomatitis [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. days until healing [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890524


Contacts
Contact: Yasusei Kudo, DDS, PhD +81 88-633-7327 yasusei@tokushima-u.ac.jp

Locations
Japan
Tada Dental Clinic Recruiting
Kakogawa, Hyogo, Japan, 675-0121
Contact: Hidesuke Tada, DDS    +81 79-430-0118    hidebupq333@gmail.com   
Tokushima University Hospital Recruiting
Tokushima, Japan, 770-8503
Contact: Yasusei Kudo, DDS, PhD    +81 88 633-7327    yasusei@tokushima-u.ac.jp   
Sponsors and Collaborators
University of Tokushima
Investigators
Principal Investigator: Yasusei Kudo, DDS, PhD Tokushima University

Responsible Party: Yasusei Kudo, Associate Professor, University of Tokushima
ClinicalTrials.gov Identifier: NCT02890524     History of Changes
Other Study ID Numbers: Tokushima #2053
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yasusei Kudo, University of Tokushima:
aphthous stomatitis
night guard
inflammatory cytokine

Additional relevant MeSH terms:
Stomatitis
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases