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NCT02340663 · ClinicalTrials.gov registry record · NA
Nocturnal Mouth Guards, SOVA vs. Standard Acrylic Orthotic; Phase IV
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 67
- Enrollment target
NCT02340663: Completed NA study, sponsored by University of Michigan.
NCT02340663 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 67 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02340663, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 67 participants
- Enrollment target
Study Summary
Clinical trials of bite splint use and night time tooth grinding have not been performed. Consequently, there are no definitive outcome measures or efficacy standards that can be applied to large clinical trials. The present preliminary trial will determine what objective measures can be used to evaluate efficacy. The outcome variables will fall into four categories: (1) fabrication efficacy, (2) compliance, (3) functional efficacy, and (4) user satisfaction. The immediate goals will: (1) focus on the over-the counter SOVA night guard, (2) conduct tests under controlled clinical conditions using the 'gold standard', the acrylic 'bite splint' or 'orthotic', hereafter called the "Michigan bite splint", to compare the performance and efficacy of the SOVA night guard. Subsequent studies will be able to use the outcome variables identified in this study for broader clinical trials. Specific Aim 1. To compare the SOVA night guard to the custom-acrylic Michigan bite splint in clinical laboratory conditions. Hypothesis: There will be no significant differences between the devices in terms of fabrication efficacy, functional efficacy or user satisfaction. Specific Aim 2. To compare the SOVA night guard to the custom-acrylic Michigan bite splint under ecologically relevant conditions, i.e., the home environment. Hypothesis: There will be no significant differences between the devices in terms of compliance or functional efficacy.
Primary Outcome
Count of the total number of entire nights that subjects wore the splint provided to them in the study.
Interventions
- DEVICE SOVA Bite Splint
- DEVICE Michigan Bite Splint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-05-10 |
| Phase | NA |
What the finished NCT02340663 record still lists
NCT02340663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which SOVA Bite Splint is the first listed.
NCT02340663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02340663 about?
NCT02340663 is a clinical study titled "Nocturnal Mouth Guards, SOVA vs. Standard Acrylic Orthotic; Phase IV". Clinical trials of bite splint use and night time tooth grinding have not been performed. Consequently, there are no definitive outcome measures or efficacy standards that can be applied to large clinical trials. The present preliminary trial will determine what objective measures can be used to eva...
What is the current status of trial NCT02340663?
This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 2015-11. Estimated completion is 2017-05-10.
What interventions are being tested in trial NCT02340663?
The interventions under investigation include: SOVA Bite Splint (DEVICE), Michigan Bite Splint (DEVICE).
Who is sponsoring clinical trial NCT02340663?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02340663's enrollment target sits among peer trials
67 1139th of 2000 higher than 862 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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