NCT02890524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

3.7 years

First QC Date

August 21, 2016

Last Update Submit

April 15, 2019

Conditions

Aphthous Stomatitis

Keywords

aphthous stomatitisnight guardinflammatory cytokine

Outcome Measures

Primary Outcomes (1)

  • number of developed aphthous stomatitis

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • days until healing

    through study completion, an average of 1 year

Study Arms (2)

Night guard

EXPERIMENTAL

the night guard made of EVA

Device: night guard

Placebo night guard

PLACEBO COMPARATOR

Placebo night guard made of EVA

Device: placebo night guard

Interventions

night guardDEVICE

60 days before and after intervention with the night guard

Night guard
placebo night guardDEVICE

60 days before and after intervention with the placebo night guard

Placebo night guard

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffered from recurrent aphthous stomatitis at least once a month

You may not qualify if:

  • People do not have a experience of recurrent aphthous stomatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tada Dental Clinic

Kakogawa, Hyōgo, 675-0121, Japan

Location

Tokushima University Hospital

Tokushima, 770-8503, Japan

Location

MeSH Terms

Conditions

Stomatitis, Aphthous

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Yasusei Kudo, DDS, PhD

    Tokushima University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 21, 2016

First Posted

September 7, 2016

Study Start

July 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

JP(2)