Tokushima Night Guard for Recurrent Aphthous Stomatitis

Aphthous Stomatitis Clinical Trial

Official title:

Effects of a Night Guard on Aphthous Stomatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890524
• Other study ID #: Tokushima #2053
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: March 2018

Study information

• Verified date: April 2019
• Source: University of Tokushima
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aphthous Stomatitis
• Stomatitis
• Stomatitis, Aphthous

Intervention

Device:
• night guard
60 days before and after intervention with the night guard
• placebo night guard
60 days before and after intervention with the placebo night guard

Locations

Country	Name	City	State
Japan	Tada Dental Clinic	Kakogawa	Hyogo
Japan	Tokushima University Hospital	Tokushima

Sponsors (1)

Lead Sponsor	Collaborator
University of Tokushima

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of developed aphthous stomatitis		through study completion, an average of 1 year
Secondary	days until healing		through study completion, an average of 1 year