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

NCT02340663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2018-07-09

Study results available
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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.

Conditions

  • Sleep Bruxism
  • Tooth Wear

Interventions

DEVICE

SOVA Bite Splint

Over-the-counter thermoplastic bite splint blank, heated, molded to fit.

DEVICE

Michigan Bite Splint

Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit

Sponsors & Collaborators

Principal Investigators

  • Geoffrey Gerstner, DDS, MS, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-05-10
Completion
2017-05-10

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02340663 on ClinicalTrials.gov