Nocturnal Mouth Guards, SOVA vs. Standard Acrylic Orthotic; Phase IV
Completed · Not applicable
Conditions studied: Sleep Bruxism, Tooth Wear
In brief
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.
Key facts
- Study ID
- NCT02340663
- Run by
- University of Michigan
- People needed
- 67
- Starts
- 2015-11-01
- Expected to finish
- 2017-05-10
- Last updated by the study team
- 2018-07-09
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult
- Tooth wear
- Night time grinding and clenching noises
- Full dentition sans 3rd molars
- Ability to follow instructions
- Ability to report to the clinical laboratory at appointed times over the course of the study.
You may not qualify if…
- Decayed, missing teeth
- Cardiovascular disease
- Sleep apnea, sleep disorders, movement disorders
- Active orthodontics
- Periodontal disease
- Partial or full dentures
- Medications with movement disorders as side effects
Where it is running
- University of Michigan School of Dentistry — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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