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Tokushima Night Guard for Recurrent Aphthous Stomatitis

Primary Purpose

Aphthous Stomatitis

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

night guard

placebo night guard

About this trial

This is an interventional prevention trial for Aphthous Stomatitis focused on measuring aphthous stomatitis, night guard, inflammatory cytokine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Tada Dental Clinic
Tokushima University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Night guard

Placebo night guard

Arm Description

the night guard made of EVA

Placebo night guard made of EVA

Outcomes

Primary Outcome Measures

number of developed aphthous stomatitis

Secondary Outcome Measures

days until healing

Full Information

NCT ID

NCT02890524

First Posted

August 21, 2016

Last Updated

April 15, 2019

Sponsor

University of Tokushima

1. Study Identification

Unique Protocol Identification Number

NCT02890524

Brief Title

Tokushima Night Guard for Recurrent Aphthous Stomatitis

Official Title

Effects of a Night Guard on Aphthous Stomatitis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

July 2014 (Actual)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Tokushima

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aphthous Stomatitis

Keywords

aphthous stomatitis, night guard, inflammatory cytokine

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Night guard

Arm Type

Experimental

Arm Description

the night guard made of EVA

Arm Title

Placebo night guard

Arm Type

Placebo Comparator

Arm Description

Placebo night guard made of EVA

Intervention Type

Device

Intervention Name(s)

night guard

Intervention Description

60 days before and after intervention with the night guard

Intervention Type

Device

Intervention Name(s)

placebo night guard

Intervention Description

60 days before and after intervention with the placebo night guard

Primary Outcome Measure Information:

Title

number of developed aphthous stomatitis

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

days until healing

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yasusei Kudo, DDS, PhD

Organizational Affiliation

Tokushima University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tada Dental Clinic

City

Kakogawa

State/Province

Hyogo

ZIP/Postal Code

675-0121

Country

Japan

Facility Name

Tokushima University Hospital

City

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Tokushima Night Guard for Recurrent Aphthous Stomatitis

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