Aphthous StomatitisNCT02890524
Tokushima Night Guard for Recurrent Aphthous Stomatitis
A study testing night guard in people with Aphthous Stomatitis, run by University of Tokushima at 2 sites in Japan.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Aphthous Stomatitis
- What is being tested?
- night guard
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesJapan
- Study dates
- Jul 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients suffered from recurrent aphthous stomatitis at least once a month
Who cannot join
- People do not have a experience of recurrent aphthous stomatitis
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Tada Dental Clinic
Kakogawa, Hyōgo, 675-0121
Tokushima University Hospital
Tokushima, 770-8503
About this study
Official title: Effects of a Night Guard on Aphthous Stomatitis
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.
Read the 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.
- Conditions
- Aphthous Stomatitis
- Being tested
- night guard, placebo night guard
- Keywords
- aphthous stomatitis, night guard, inflammatory cytokine
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
night guardDevice
60 days before and after intervention with the night guard
placebo night guardDevice
60 days before and after intervention with the placebo night guard
| Study group | Role | What they receive |
|---|---|---|
| Night guard | Experimental | the night guard made of EVA Receives: Device: night guard |
| Placebo night guard | Placebo comparator | Placebo night guard made of EVA Receives: Device: placebo night guard |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of developed aphthous stomatitis
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
days until healing
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJul 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphthous StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tokushima
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasusei Kudo, University of Tokushima
- Investigators
- Yasusei Kudo, DDS, PhD, Principal investigator, Tokushima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890524
- Sponsor's protocol ID
- Tokushima #2053
- Status last verified
- Apr 2019
- First submitted
- 21 Aug 2016
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Night Guard on Aphthous Stomatitis
- ClinicalTrials.gov ID
- NCT02890524
- Acronym / sponsor ID
- Tokushima #2053
- Conditions
- Aphthous Stomatitis
- Keywords
- aphthous stomatitis, night guard, inflammatory cytokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of TokushimaUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Night guard | Experimental | Device: night guardthe night guard made of EVA |
| Placebo night guard | Placebo comparator | Device: placebo night guardPlacebo night guard made of EVA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffered from recurrent aphthous stomatitis at least once a month
Key exclusion criteria (1 listed)
- People do not have a experience of recurrent aphthous stomatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| night guard60 days before and after intervention with the night guard | Device | Night guard |
| placebo night guard60 days before and after intervention with the placebo night guard | Device | Placebo night guard |
Primary outcome
number of developed aphthous stomatitis
Time frame: through study completion, an average of 1 year
1 secondary outcome
days until healing
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasusei Kudo, DDS, PhD principal investigator
Tokushima University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing night guard in people with Aphthous Stomatitis, run by University of Tokushima at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of developed aphthous stomatitis (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.