NCT02340663

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 9, 2018

Completed
Last Updated

July 9, 2018

Status Verified

June 1, 2018

Enrollment Period

1.5 years

First QC Date

January 13, 2015

Results QC Date

May 4, 2018

Last Update Submit

June 8, 2018

Conditions

Sleep BruxismTooth Wear

Keywords

dental orthoticbite splintoral parafunctionclenchinggrinding

Outcome Measures

Primary Outcomes (1)

  • Total Number of Nights of Splint Wear for Four Months Per Subject.

    Count of the total number of entire nights that subjects wore the splint provided to them in the study.

    4 months

Secondary Outcomes (25)

  • Number of Bruxing Events Per Hour Sleep Per Night.

    4 months

  • Splint Material Loss / 4 Months.

    4 months

  • Compliance -- Appliance Removal at Night

    4 months

  • Compliance -- Use of Alternative Devices

    4 months

  • Functional Efficacy -- Tooth Wear

    4 months

  • +20 more secondary outcomes

Study Arms (2)

SOVA bite splint

EXPERIMENTAL

SOVA Bite splint: Over-the-counter, heat-and-mold bite splint. Investigators evaluate subject self-fabrication, and evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 3 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months.

Device: SOVA Bite Splint

Michigan Bite Splint

ACTIVE COMPARATOR

Michigan bite splint: Gold standard, custom acrylic bite splint made for subjects. Investigators evaluate fit. Subjects wear splint nightly for one week. Polysomnographic data obtained from one night during the week. Subjects continue to wear splint for 3 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months.

Device: Michigan Bite Splint

Interventions

SOVA Bite SplintDEVICE

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

SOVA bite splint
Michigan Bite SplintDEVICE

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

Michigan Bite Splint

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109-1078, United States

Location

Related Publications (11)

  • Cunha-Cruz J, Pashova H, Packard JD, Zhou L, Hilton TJ; for Northwest PRECEDENT. Tooth wear: prevalence and associated factors in general practice patients. Community Dent Oral Epidemiol. 2010 Jun;38(3):228-34. doi: 10.1111/j.1600-0528.2010.00537.x. Epub 2010 Mar 29.

    PMID: 20370807BACKGROUND

  • Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. No abstract available.

    PMID: 1298767BACKGROUND

  • Fricton J, Look JO, Wright E, Alencar FG Jr, Chen H, Lang M, Ouyang W, Velly AM. Systematic review and meta-analysis of randomized controlled trials evaluating intraoral orthopedic appliances for temporomandibular disorders. J Orofac Pain. 2010 Summer;24(3):237-54.

    PMID: 20664825BACKGROUND

  • Gonzalez YM, Schiffman E, Gordon SM, Seago B, Truelove EL, Slade G, Ohrbach R. Development of a brief and effective temporomandibular disorder pain screening questionnaire: reliability and validity. J Am Dent Assoc. 2011 Oct;142(10):1183-91. doi: 10.14219/jada.archive.2011.0088.

    PMID: 21965492BACKGROUND

  • Huynh N, Manzini C, Rompre PH, Lavigne GJ. Weighing the potential effectiveness of various treatments for sleep bruxism. J Can Dent Assoc. 2007 Oct;73(8):727-30.

    PMID: 17949541BACKGROUND

  • Klasser GD, Greene CS, Lavigne GJ. Oral appliances and the management of sleep bruxism in adults: a century of clinical applications and search for mechanisms. Int J Prosthodont. 2010 Sep-Oct;23(5):453-62.

    PMID: 20859563BACKGROUND

  • Lin AI, Braun T, McNamara JA Jr, Gerstner GE. Esthetic evaluation of dynamic smiles with attention to facial muscle activity. Am J Orthod Dentofacial Orthop. 2013 Jun;143(6):819-27. doi: 10.1016/j.ajodo.2013.01.017.

    PMID: 23726332BACKGROUND

  • Maeda Y, Kumamoto D, Yagi K, Ikebe K. Effectiveness and fabrication of mouthguards. Dent Traumatol. 2009 Dec;25(6):556-564. doi: 10.1111/j.1600-9657.2009.00822.x. Epub 2009 Sep 24.

    PMID: 19788425BACKGROUND

  • Monse B, Duijster D, Sheiham A, Grijalva-Eternod CS, van Palenstein Helderman W, Hobdell MH. The effects of extraction of pulpally involved primary teeth on weight, height and BMI in underweight Filipino children. A cluster randomized clinical trial. BMC Public Health. 2012 Aug 31;12:725. doi: 10.1186/1471-2458-12-725.

    PMID: 22938147BACKGROUND

  • Ohrbach R, Larsson P, List T. The jaw functional limitation scale: development, reliability, and validity of 8-item and 20-item versions. J Orofac Pain. 2008 Summer;22(3):219-30.

    PMID: 18780535BACKGROUND

  • Gerstner G, Yao W, Siripurapu K, Aljanabi H, Decker A, Ludkin D, Sinacola R, Frimenko K, Callaghan K, Penoyer S, Tewksbury C. Over-the-counter bite splints: A randomized controlled trial of compliance and efficacy. Clin Exp Dent Res. 2020 Dec;6(6):626-641. doi: 10.1002/cre2.315. Epub 2020 Aug 10.

    PMID: 32779386DERIVED

MeSH Terms

Conditions

Sleep BruxismTooth Wear

Condition Hierarchy (Ancestors)

BruxismTooth DiseasesStomatognathic DiseasesParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
Dr. Geoffrey Gerstner
Organization
University of Michigan
geger@umich.edu
734-763-7717

Study Officials

  • Geoffrey Gerstner, DDS, MS, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 16, 2015

Study Start

November 1, 2015

Primary Completion

May 10, 2017

Study Completion

May 10, 2017

Last Updated

July 9, 2018

Results First Posted

July 9, 2018

Record last verified: 2018-06

Locations

US(1)