An interventional study of night guard and placebo night guard in Aphthous Stomatitis, sponsored by University of Tokushima. Completed at 2 sites in Japan. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by University of Tokushima · Not applicable, Interventional, and Prevention
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.
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.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 20 is below the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →University of Tokushima is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
the night guard made of EVA
Device: night guard
Placebo night guard made of EVA
Device: placebo night guard
60 days before and after intervention with the night guard
60 days before and after intervention with the placebo night guard
number of developed aphthous stomatitis
Time frame: through study completion, an average of 1 year
days until healing
Time frame: through study completion, an average of 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jul 2014 to primary completion in Mar 2018, 44 months.
Of 13 interventional studies with no phase under Stomatitis, Aphthous, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's 44 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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University of Tokushima