N/A N=67 Randomized Single-blind Supportive Care

Nocturnal Mouth Guards, SOVA vs. Standard Acrylic Orthotic; Phase IV

Sleep Bruxism · Tooth Wear

Bottom Line

View on ClinicalTrials.gov: NCT02340663 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Total Number of Nights of Splint Wear for Four Months Per Subject. — 93.6; 98.7 nights — p=0.23

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SOVA Bite Splint (Device); Michigan Bite Splint (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Number of Nights of Splint Wear for Four Months Per Subject.	93.6; 98.7	0.23
SECONDARY Number of Bruxing Events Per Hour Sleep Per Night.	52.9; 41.5	0.045 sig
SECONDARY Splint Material Loss / 4 Months.	-0.20; -0.17	0.665
SECONDARY Compliance -- Appliance Removal at Night	1.2; 0.8	0.249
SECONDARY Compliance -- Use of Alternative Devices	0.6; 0.5	0.626
SECONDARY Functional Efficacy -- Tooth Wear	-.060; -.053	0.695
SECONDARY Functional Efficacy -- Alteration of Bruxism Habit, Self Report of Reduced Bruxism	2.7; 3.0	0.255
SECONDARY Functional Efficacy -- Alteration of Bruxism Habit, Self-Report of Muscle Relaxation	1.9; 2.5	.049 sig
SECONDARY User Satisfaction -- Ease of Fabrication	1; 3; 1; 13; 11	—
SECONDARY User Satisfaction -- Ease of Instructions	0; 1; 2; 16; 10	—
SECONDARY User Satisfaction -- Self-Report of Splint Fit	3.1; 3.3	0.750
SECONDARY Fabrication Efficacy -- Estimated Bite Forces During Stability Testing	28.4; 16.7; 24.4; 11.7; 49.7; 35.5	<0.01 sig
SECONDARY Fabrication Efficacy -- Retention Trials Week 1	1.1; 0.6	0.544
SECONDARY Fabrication Efficacy -- Retention Trials, Month 4	1.7; 0.6	0.220
SECONDARY Fabrication Efficacy -- Tissue Adaptation, Palatal Rim. Number of Participants With Poor Adaptation	7; 2	0.081
SECONDARY Fabrication Efficacy -- Tissue Adaptation, Facial Rim. Number of Participants With Poor Adaptation	4; 4	1.0
SECONDARY Fabrication Efficacy -- Tissue Adaptation, Number of Subjects Whose Splints Had Excessive Material	5; 4	0.731
SECONDARY Fabrication Efficacy -- Tissue Adaptation, Tightness. Number of Participants Reporting Excessive Tightness	0; 3	0.238
SECONDARY Fabrication Efficacy -- Oral Health Plaque Index	0.46; 0.42; 0.46; 0.38; 0.41; 0.43	0.952
SECONDARY Fabrication Efficacy -- Oral Health Modified Gingival Index	0.96; 0.92; 1.02; 1.00; 0.87; 0.92	0.53
SECONDARY Stability -- Splint Movement During Jaw Movement Tasks	0.72; 0.71; 0.83; 0.78; 0.63; 1.12	0.292
SECONDARY Stability -- Number of Splints Dislodged by Clenching	26; 27; 2; 1; 1; 1	0.289
SECONDARY Stability -- Number of Splints Dislodged by Grinding	26; 23; 3; 4; 0; 2	0.287
SECONDARY Stability -- Number of Splints Dislodged During Border Movement Trials	28; 20; 0; 5; 1; 2	0.505
SECONDARY Stability -- Number of Splints Dislodged by Tapping	28; 28; 2; 2	0.643
SECONDARY Stability -- Number of Splints Dislodged During Maximum Openings	18; 13; 7; 8; 2; 2	0.923

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02340663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.