Sleep BruxismSISU-SOVANCT02340663
Nocturnal Mouth Guards, SOVA vs. Standard Acrylic Orthotic; Phase IV
A study testing SOVA Bite Splint and Michigan Bite Splint in people with Sleep Bruxism and Tooth Wear, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Bruxism, Tooth Wear
- What is being tested?
- SOVA Bite Splint and Michigan Bite Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 10 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109-1078
About this study
Official title: Preliminary Phase IV Trial Comparing the SOVA Night Guard With the Clinical Standard Acrylic Orthotic
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.
Read the detailed description
Subjects. Sample size estimations are based upon a recent review of randomized clinical trials, in which acrylic appliances were evaluated (see Appendix 2 in (Huynh et al., 2007)). The mean +/- 1 standard deviation (SD) number of bruxism episodes per hour with a Michigan bite splint was 3.97 + 0.58, and for a palatal splint, the mean +/- 1 SD was 4.45 + 0.63. Using these means and the higher SD (0.63), along with an alpha = 0.05 and beta = 0.8, a study would be sufficiently powered with sample sizes of 29 per group. Based on other Michigan studies, wherein recruitment, exclusion and attrition rates are known, it is estimated that an initial screening sample size of 120 will be necessary to end up with 29 per group.
There will be two treatment groups: a group receiving supervised training in the fabrication of the SOVA night guard (SOVA) and a group receiving the Michigan custom-acrylic bite splint (MI BS). Two groups times 29 subjects per group equals 58 total needed for analysis.
Care will be taken to match the randomized groups for age, ethnicity, gender and temporomandibular disorders (TMD) signs/symptoms. Alternatively these will be modeled as nuisance variables if attrition rates create bias or there is a lack of sufficiently sized screening pools.
Screening. Candidates will undergo a screening to assess co-morbidities and to identify inclusion and exclusion criteria. Standard questionnaires and screening instruments and a brief clinical exam will be performed. Subjects meeting the acceptance criteria will be randomly assigned to one of the two groups using stratified randomization procedures (Suresh, 2011). Alginate impressions will be taken, and impressions poured in stone. The models will be used either to fabricate the MI BS or to assess SOVA appliances for fabrication efficacy.
Splint delivery. For the SOVA group, subjects will be asked to fabricate SOVA devices in the clinical laboratory while receiving feedback from trained and calibrated study 'instructors'. Fabrication will use manufacturer instructions. Calibrated instructors will be blinded to the study's objectives, as will subjects. A "Michigan" acrylic bite splint will be fabricated using standard clinical practice and checked for fit and quality on subjects assigned to the MI BS group.
Subjective fabrication assessment. Standardized questionnaires and box scales will be used to assess ease of fabrication, ease of instructions, and other related issues for the devices.
Quantitative fabrication assessments. Four aspects of fabrication will be evaluated by investigators: (1) stability-does the device move independently of the maxilla and is the mandible stabilized by the device, (2) retention-does the device resist displacement, (3) tissue adaptation-how much spacing exists between the maxilla and the device and between the device and mandible, and (4) health of the teeth, gingival, tongue, palate and lips.
Stability and retention will be quantitatively assessed with jaw movement (MaxTraq motion analysis system, Innovision, Columbiaville, MI) and electromyography (EMG) (LabChart, ADInstruments, Colorado Springs, CO) data and force sensors. For position-stability assessment, maxilla, mandible and the splint will be simultaneously recorded from at least three sites to capture 6 degrees of movement freedom. Subjects will clench, grind, perform closed border movements and vacuous chewing (verified with EMG and force sensors). For retention assessment, subjects will perform a series of tests designed to dislodge the device, e.g., tapping, forced blowing, coughing, chewing on gum. Stability and retention indices will be created based on whether device movements vary independently of jaw movements and applied bite forces, and how force sensor output varies during dislodgement exercises. Deviations will be used to form standardized indices of stability and retention, with smaller values representing greater stability and retention. Note that a major part of the study will be to develop the appropriate methods to make these measurements, as it is not clear how this should be done ideally.
Tissue adaptation will be assessed by 3D laser scanner. The occlusal, facial and lingual surfaces of the upper arch will be scanned as will the inner surface of the night guards. An index of adaptation will be developed based on the volumetric spaces separating the teeth from the device, using topological software. Smaller volumes will represent better tissue adaptation. Volumetric indices will be compared between devices via ANOVA or appropriate statistical methods. Note that a major part of this study will be to develop an accurate and precise way of measuring volumetric spacing, as such methods have not yet been developed.
Tissue health will be assessed via appropriate, standard methods currently used in cariology and periodontology clinical studies (Monse et al., 2012; Tirapellia et al., 2010). Baseline measurements will be compared with post-device wear measurements. Between-group differences will be studied with a repeated measures ANOVA or appropriate statistical methods.
Compliance assessment. Compliance assessments will focus on: (1) how often the device is worn, (2) whether the device is removed at inappropriate times during the night, (3) whether alternative devices are used. Compliance will be assessed via subject self-report, nocturnal EMG recording devices and microwear methods. Subjects would be blinded to the purpose of the technological methods. Occlusal microwear patterns are unique to the surfaces against which occlusion occurs, and the microwear changes on a daily basis (Ungar et al., 2003). Hence, microwear assessment should provide definitive evidence of splint compliance. Microwear analysis methods will be developed as part of this study for these purposes.
Functional efficacy. Two questions will be addressed under functional efficacy: (1) does the device alter bruxing activity, and (2) how do the teeth and device hold up under bruxing activity. Some of the technology used for compliance assessment, above, can be used here. Gold standard methods for evaluating bruxing activity rely on polysomnography (PSG) and EMG activity; therefore, it these technologies will be used as well. To address the second question, how do the teeth hold up, 3-D laser scanning technology will be developed and used to measure changes in macroscopic tooth structure, and confocal microscopy and scale-sensitive fractal analysis will be assessed for utility in diagnosing microwear.
User satisfaction. This will be assessed through a series of standardized questionnaires adopted from other clinical studies, e.g., the Oral Health Impact Profile (Slade and Spencer, 1994), the Tampa Scale for Kinesiophobia: TMD (Visscher et al., 2010), the TMD pain screener (Gonzalez et al., 2011). Questionnaires used in the SISU field tests (SISU mouthguards preliminary results), as well as forced choice, box scales and statistical methods developed in another study (Lin, 2008; Lin et al., 2013) will also prove useful for assessment of patient satisfaction. Also questions such as, does the device hurt or pinch anywhere, does your bite feel 'off' when you first remove the guard, etc. will be used to assess specific aspects of user satisfaction.
Repeated measures (Week 1 check-up and 4 Month check-up). Compliance, stability, retention, tissue adaptation and health, functional efficacy and user satisfaction will be assessed two times, viz., 1 week after delivery and 4 months after delivery. This will provide a rigorous data set, reduce subject attrition and thus allow for both publications and further clinical trials to be pursued.
- Conditions
- Sleep Bruxism, Tooth Wear
- Being tested
- SOVA Bite Splint, Michigan Bite Splint
- Keywords
- dental orthotic, bite splint, oral parafunction, clenching, grinding
- Medical subject headings
- Sleep Bruxism, Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOVA Bite SplintDevice
Over-the-counter thermoplastic bite splint blank, heated, molded to fit.
Michigan Bite SplintDevice
Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Michigan Bite Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (25)
Number of Bruxing Events Per Hour Sleep Per Night.
Polysomnographic monitors were used to evaluate masticatory muscle activity during sleep. Activity of jaw closing muscles found in the cheeks (masseter muscles) occur in bursts, where a burst is taken as evidence for a jaw clench. The total number of bursts recorded during the night was tabulated and then divided by the total hours of sleep. Means presented are based on data gathered on night 122 (4 months of splint wear) and compared with ANOVA.
Measured: 4 months
Splint Material Loss / 4 Months.
Splint wear measured in millimeters. The number is negative to reflect the amount lost, e.g., -0.1 = a tenth of a millimeter lost. High-resolution, computer-scanned models of the splint on the delivery date were combined with high-resolution, computer-scanned models of the same splint after 4 months of wear. Sites where teeth contacted the splints were identified, and material loss in these areas was quantified using a computer program designed to quantify differences between two computer models. The measurement represents the difference between the two models, defined by a mean value sampled from a standard-sized area, which was set to be about the size of a tooth cusp (~ 3 millimeters in diameter). Group means were compared with t-tests.
Measured: 4 months
Compliance -- Appliance Removal at Night
Responses to the question, "I frequently remove the splint during the night" with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out at the end of 4 months of splint wear.
Measured: 4 months
Compliance -- Use of Alternative Devices
Responses to the question, "I use an additional splint" with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out at the end of 4 months of splint wear.
Measured: 4 months
Functional Efficacy -- Tooth Wear
Tooth wear measured in millimeters. The number is negative to reflect the amount lost, e.g., -0.1 = a tenth of a millimeter lost. High-resolution, computer-scanned models of the teeth in the lower jaw on the delivery data were combined with high-resolution, computer-scanned models of the same teeth and jaw after 4 months of splint wear. Sites where teeth showed cratering due to dentin exposure were targeted to make these measurements. Changes in these areas was quantified using a computer program designed to quantify differences between two computer models. The measurement represents the difference between the two models, defined by a mean value sampled from a standard-sized area, which was set to be about the size of dentin exposure areas (~ 1 millimeter in diameter). Group means were compared with t-tests.
Measured: 4 months
Functional Efficacy -- Alteration of Bruxism Habit, Self Report of Reduced Bruxism
Responses to the question, "The splint helps my bruxism." with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out at the end of 4 months of splint wear.
Measured: 4 months
Functional Efficacy -- Alteration of Bruxism Habit, Self-Report of Muscle Relaxation
Responses to the question, "The splint relaxes my jaw muscles." with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out at the end of 4 months of splint wear.
Measured: 4 months
User Satisfaction -- Ease of Fabrication
Responses to the question, "The splint was easy to fabricate" with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out at the end of the appointment during which time the splints were made by participants.
Measured: On day of delivery
User Satisfaction -- Ease of Instructions
Responses to the question, "The instructions were easy to follow" with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out at the end of the appointment during which time the splints were made by participants.
Measured: On day of delivery
User Satisfaction -- Self-Report of Splint Fit
Responses to the question, "The splint fits well" with a 5-point Likert scale, anchored on the left with "Strongly Disagree" (receiving a score of 0) and on the right with "Strongly Agree" (receiving a score of 4). Question was filled out during the final appointment.
Measured: 4 months
Fabrication Efficacy -- Estimated Bite Forces During Stability Testing
Estimated bite forces in kilograms associated with performing each of the following tasks: moving the jaw in extreme positions with pressure against the splint (Border), clenching (Clench), grinding side to side (Grind Lateral), grinding front to back (Grind Protrusive), tapping hard on splint (Tap). Overall means for each treatment group (SOVA and Michigan splints) are also reported.
Measured: 4 months
Fabrication Efficacy -- Retention Trials Week 1
Number of times splint was dislodged while performing eight different movements, with each movement being performed five times (maximum number therefore = 40). Dislodgement meant that, after performing the movement, the splint either fell off the teeth completely or that biting down on the splint resulted in its being reseated on the teeth.
Measured: 1 week
Fabrication Efficacy -- Retention Trials, Month 4
Number of times splint was dislodged while performing eight different movements, with each movement being performed five times (maximum number therefore = 40). Dislodgement meant that, after performing the movement, the splint either fell off the teeth completely or that biting down on the splint resulted in its being reseated on the teeth.
Measured: 4 months
Fabrication Efficacy -- Tissue Adaptation, Palatal Rim. Number of Participants With Poor Adaptation
Palate-side of splints was evaluated for contact with the palate. Splints that were > 1 mm from contact with palate, from molar to molar were graded as 1 (poor adaptation); splints in continuous contact or lacking contact < 1mm with palate, from molar to molar were graded as 0 (good adaptation). Number of participants with splints in each group with poor adaptation is reported.
Measured: Day of delivery
Fabrication Efficacy -- Tissue Adaptation, Facial Rim. Number of Participants With Poor Adaptation
Lip- and cheek-sides of splints were evaluated for contact with the premolar and molar teeth. Splints lacking contact (> 1 mm space between splint and teeth) were graded as 1 (poor adaptation); splints with < 1 mm space between splint and teeth, from molar to molar as 0 (good adaptation). Inter-proximal contacts Number of total participants with splints in each group with poor adaptation is reported.
Measured: Day of Delivery
Fabrication Efficacy -- Tissue Adaptation, Number of Subjects Whose Splints Had Excessive Material
Splint rims were evaluated for thickness. Splints requiring modification by the attending dentist to remove excess material were graded as 1 (poor adaptation); splints that did not require removal of excess material were graded as 0 (good adaptation). Number of participants in each group whose splint manifest poor adaptation is reported.
Measured: Day of Delivery
Fabrication Efficacy -- Tissue Adaptation, Tightness. Number of Participants Reporting Excessive Tightness
Splints were evaluated for sensation of tightness on the teeth. SOVA splints that were said to be too tight by the participants and that subsequently required intervention by the attending dentist to fix were graded as 1 (poor adaptation); Michigan splints that were said to be too tight by the participants and that required the attending dentist to spend > 15 minutes of the delivery appointment to fix were graded as 1 (poor adaptation); all splints not meeting these criteria were scored as 0 (good adaptation). Total participants in each group with poorly adapted splints is reported.
Measured: Day of Delivery
Fabrication Efficacy -- Oral Health Plaque Index
The Rustogi et al. Modification of the Navy Plaque Index method of scoring plaque was used. This involves dividing the cheek-facing (Buccal) and the tongue/palate-facing (Lingual) surfaces of each tooth into 9 regions and scoring whether disclosed plaque is present (1) or absent (0) in each of these 9 regions. The total number of regions with plaque was then tabulated as the proportion of total regions for four mouth areas, viz., the cheek sides of the upper teeth (Buccal Upper), the cheek sides of the lower teeth (Buccal Lower), the palate sides of the upper teeth (Lingual Upper) and the tongue sides of the lower teeth (Lingual Lower). Overall means for each treatment group (SOVA and Michigan splints) are also reported.
Measured: 1 week and 4 months
Fabrication Efficacy -- Oral Health Modified Gingival Index
Gums or gingiva around each tooth is quantified for absence of inflammation (0), mild inflammation around part of the gingiva next to the tooth (1), mild inflammation involving all of the gingiva next to the tooth (2), moderate inflammation (3), or severe inflammation (4). Average scores are created for the cheek side of the upper teeth (Buccal Upper), palate side of upper teeth (Lingual Upper), cheek side of lower teeth (Buccal Lower) and tongue side of lower teeth (Lingual Lower). Mean and standard deviation scores for each of these regions and for week 1 and month 4 are shown as descriptive statistics; statistical results for the between-subject effects are reported. Overall means for each treatment group (SOVA and Michigan splints) are also reported.
Measured: 1 week and 4 months
Stability -- Splint Movement During Jaw Movement Tasks
Movement of each subject's splint on the teeth, due to rocking or dislodgement, measured in millimeters during five repetitions of the following five tasks: clenching, grinding, moving jaw to extreme positions on the splint, tapping, opening maximally. For control, movements of the splint while the jaw was in a rest position (teeth apart, jaw relaxed) were also measured. The maximum movement during the five repetitions of each task was calculated for each subject and used in statistical analyses.
Measured: 4 months
Stability -- Number of Splints Dislodged by Clenching
Count of the number of participants whose individual splints were dislodged at least once when participants clenched their teeth against the splint five times. Numbers are sorted into those that moved < 1 mm, those that moved between 1 - 2 mm, those that moved between 2 - 3 mm and those that moved > 6 mm during the performance of five repeats of clenching. Categories from 3 mm to 6 mm are not included, because no splints fell into this range of values.
Measured: 4 months
Stability -- Number of Splints Dislodged by Grinding
Count of the number of participants whose individual splints were dislodged at least once when participants ground their teeth against the splint to the left (5 times), to the right (5 times, and front to back (5 times). Count is partitioned into those dislodged by < 1 mm, between 1 - 2 mm, between 2 - 3 mm, between 3 - 4 mm, and > 6 mm. Categories between 4 and 6 mm are not included, as no splints fell into this range.
Measured: 4 Months
Stability -- Number of Splints Dislodged During Border Movement Trials
Count of the number of participants whose individual splints were dislodged at least once when participants performed grinding-like movements of the teeth against the splint in extreme positions. These extreme movements and positions were performed 5 times. Counts are partitioned into those dislodged > 1 mm, those dislodged between 1 - 2 mm, those dislodged 2 - 3 mm, those dislodged 3 - 4 mm, those dislodged 4 - 5 mm, those dislodged 5 - 6 mm and those dislodged > 6 mm.
Measured: 4 months
Stability -- Number of Splints Dislodged by Tapping
Count of the number of participants whose individual splints were dislodged at least once when participants tapped their teeth on the splint 5 times. Counts are partitioned into the number dislodged < 1 mm, and those dislodged between 1 - 2 mm.
Measured: 4 months
Stability -- Number of Splints Dislodged During Maximum Openings
Count of the number of participants whose individual splints were dislodged at least once when participants opened as wide as possible and then closed. The task was repeated five times. Counts are partitioned into the number dislodged < 1 mm, number dislodged between 1 - 2 mm, number dislodged between 2 - 3 mm, number dislodged between 3 - 4 mm and number dislodged between 4 - 5 mm.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startNov 2015
- Primary completion10 May 2017
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Sleep BruxismStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Delta Dental Fund of Michigan
- Responsible party
- Principal investigator, Geoffrey E. Gerstner, University of Michigan
- Investigators
- Geoffrey Gerstner, DDS, MS, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340663
- Sponsor's protocol ID
- HUM00085489
- Acronym
- SISU-SOVA
- Status last verified
- Jun 2018
- First submitted
- 13 Jan 2015
- Last updated
- 9 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20370807Dworkin 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.
PubMed 1298767Fricton 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.
PubMed 20664825Gonzalez 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.
PubMed 21965492Huynh 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.
PubMed 17949541Klasser 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.
PubMed 20859563Lin 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.
PubMed 23726332Maeda 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.
PubMed 19788425Monse 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.
PubMed 22938147Ohrbach 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.
PubMed 18780535Gerstner 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.
PubMed 32779386
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Phase IV Trial Comparing the SOVA Night Guard With the Clinical Standard Acrylic Orthotic
- ClinicalTrials.gov ID
- NCT02340663
- Acronym / sponsor ID
- SISU-SOVA / HUM00085489
- Conditions
- Sleep Bruxism, Tooth Wear
- Keywords
- dental orthotic, bite splint, oral parafunction, clenching, grinding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Delta Dental Fund of Michigan
- Study start
- Nov 2015
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Posted 9 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects. Sample size estimations are based upon a recent review of randomized clinical trials, in which acrylic appliances were evaluated (see Appendix 2 in (Huynh et al., 2007)). The mean +/- 1 standard deviation (SD) number of bruxism episodes per hour with a Michigan bite splint was 3.97 + 0.58, and for a palatal splint, the mean +/- 1 SD was 4.45 + 0.63. Using these means and the higher SD (0.63), along with an alpha = 0.05 and beta = 0.8, a study would be sufficiently powered with sample sizes of 29 per group. Based on other Michigan studies, wherein recruitment, exclusion and attrition rates are known, it is estimated that an initial screening sample size of 120 will be necessary to end up with 29 per group.
There will be two treatment groups: a group receiving supervised training in the fabrication of the SOVA night guard (SOVA) and a group receiving the Michigan custom-acrylic bite splint (MI BS). Two groups times 29 subjects per group equals 58 total needed for analysis.
Care will be taken to match the randomized groups for age, ethnicity, gender and temporomandibular disorders (TMD) signs/symptoms. Alternatively these will be modeled as nuisance variables if attrition rates create bias or there is a lack of sufficiently sized screening pools.
Screening. Candidates will undergo a screening to assess co-morbidities and to identify inclusion and exclusion criteria. Standard questionnaires and screening instruments and a brief clinical exam will be performed. Subjects meeting the acceptance criteria will be randomly assigned to one of the two groups using stratified randomization procedures (Suresh, 2011). Alginate impressions will be taken, and impressions poured in stone. The models will be used either to fabricate the MI BS or to assess SOVA appliances for fabrication efficacy.
Splint delivery. For the SOVA group, subjects will be asked to fabricate SOVA devices in the clinical laboratory while receiving feedback from trained and calibrated study 'instructors'. Fabrication will use manufacturer instructions. Calibrated instructors will be blinded to the study's objectives, as will subjects. A "Michigan" acrylic bite splint will be fabricated using standard clinical practice and checked for fit and quality on subjects assigned to the MI BS group.
Subjective fabrication assessment. Standardized questionnaires and box scales will be used to assess ease of fabrication, ease of instructions, and other related issues for the devices.
Quantitative fabrication assessments. Four aspects of fabrication will be evaluated by investigators: (1) stability-does the device move independently of the maxilla and is the mandible stabilized by the device, (2) retention-does the device resist displacement, (3) tissue adaptation-how much spacing exists between the maxilla and the device and between the device and mandible, and (4) health of the teeth, gingival, tongue, palate and lips.
Stability and retention will be quantitatively assessed with jaw movement (MaxTraq motion analysis system, Innovision, Columbiaville, MI) and electromyography (EMG) (LabChart, ADInstruments, Colorado Springs, CO) data and force sensors. For position-stability assessment, maxilla, mandible and the splint will be simultaneously recorded from at least three sites to capture 6 degrees of movement freedom. Subjects will clench, grind, perform closed border movements and vacuous chewing (verified with EMG and force sensors). For retention assessment, subjects will perform a series of tests designed to dislodge the device, e.g., tapping, forced blowing, coughing, chewing on gum. Stability and retention indices will be created based on whether device movements vary independently of jaw movements and applied bite forces, and how force sensor output varies during dislodgement exercises. Deviations will be used to form standardized indices of stability and retention, with smaller values representing greater stability and retention. Note that a major part of the study will be to develop the appropriate methods to make these measurements, as it is not clear how this should be done ideally.
Tissue adaptation will be assessed by 3D laser scanner. The occlusal, facial and lingual surfaces of the upper arch will be scanned as will the inner surface of the night guards. An index of adaptation will be developed based on the volumetric spaces separating the teeth from the device, using topological software. Smaller volumes will represent better tissue adaptation. Volumetric indices will be compared between devices via ANOVA or appropriate statistical methods. Note that a major part of this study will be to develop an accurate and precise way of measuring volumetric spacing, as such methods have not yet been developed.
Tissue health will be assessed via appropriate, standard methods currently used in cariology and periodontology clinical studies (Monse et al., 2012; Tirapellia et al., 2010). Baseline measurements will be compared with post-device wear measurements. Between-group differences will be studied with a repeated measures ANOVA or appropriate statistical methods.
Compliance assessment. Compliance assessments will focus on: (1) how often the device is worn, (2) whether the device is removed at inappropriate times during the night, (3) whether alternative devices are used. Compliance will be assessed via subject self-report, nocturnal EMG recording devices and microwear methods. Subjects would be blinded to the purpose of the technological methods. Occlusal microwear patterns are unique to the surfaces against which occlusion occurs, and the microwear changes on a daily basis (Ungar et al., 2003). Hence, microwear assessment should provide definitive evidence of splint compliance. Microwear analysis methods will be developed as part of this study for these purposes.
Functional efficacy. Two questions will be addressed under functional efficacy: (1) does the device alter bruxing activity, and (2) how do the teeth and device hold up under bruxing activity. Some of the technology used for compliance assessment, above, can be used here. Gold standard methods for evaluating bruxing activity rely on polysomnography (PSG) and EMG activity; therefore, it these technologies will be used as well. To address the second question, how do the teeth hold up, 3-D laser scanning technology will be developed and used to measure changes in macroscopic tooth structure, and confocal microscopy and scale-sensitive fractal analysis will be assessed for utility in diagnosing microwear.
User satisfaction. This will be assessed through a series of standardized questionnaires adopted from other clinical studies, e.g., the Oral Health Impact Profile (Slade and Spencer, 1994), the Tampa Scale for Kinesiophobia: TMD (Visscher et al., 2010), the TMD pain screener (Gonzalez et al., 2011). Questionnaires used in the SISU field tests (SISU mouthguards preliminary results), as well as forced choice, box scales and statistical methods developed in another study (Lin, 2008; Lin et al., 2013) will also prove useful for assessment of patient satisfaction. Also questions such as, does the device hurt or pinch anywhere, does your bite feel 'off' when you first remove the guard, etc. will be used to assess specific aspects of user satisfaction.
Repeated measures (Week 1 check-up and 4 Month check-up). Compliance, stability, retention, tissue adaptation and health, functional efficacy and user satisfaction will be assessed two times, viz., 1 week after delivery and 4 months after delivery. This will provide a rigorous data set, reduce subject attrition and thus allow for both publications and further clinical trials to be pursued.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOVA bite splint | Experimental | Device: SOVA Bite SplintSOVA 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. |
| Michigan Bite Splint | Active comparator | Device: Michigan Bite SplintMichigan 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult
- Tooth wear
- Night time grinding and clenching noises
- Full dentition sans 3rd molars
- Ability to follow instructions
Key exclusion criteria (7 listed)
- Decayed, missing teeth
- Cardiovascular disease
- Sleep apnea, sleep disorders, movement disorders
- Active orthodontics
- Periodontal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOVA Bite SplintOver-the-counter thermoplastic bite splint blank, heated, molded to fit. | Device | SOVA bite splint |
| Michigan Bite SplintHeat-cured acrylic bite splint fabricated by dentist/dental technician to fit | Device | Michigan Bite Splint |
Primary outcome
Total Number of Nights of Splint Wear for Four Months Per Subject.
Time frame: 4 months
Count of the total number of entire nights that subjects wore the splint provided to them in the study.
25 secondary outcomes
Number of Bruxing Events Per Hour Sleep Per Night.
Time frame: 4 months
Splint Material Loss / 4 Months.
Time frame: 4 months
Compliance -- Appliance Removal at Night
Time frame: 4 months
Compliance -- Use of Alternative Devices
Time frame: 4 months
Functional Efficacy -- Tooth Wear
Time frame: 4 months
Functional Efficacy -- Alteration of Bruxism Habit, Self Report of Reduced Bruxism
Time frame: 4 months
Functional Efficacy -- Alteration of Bruxism Habit, Self-Report of Muscle Relaxation
Time frame: 4 months
User Satisfaction -- Ease of Fabrication
Time frame: On day of delivery
User Satisfaction -- Ease of Instructions
Time frame: On day of delivery
User Satisfaction -- Self-Report of Splint Fit
Time frame: 4 months
Fabrication Efficacy -- Estimated Bite Forces During Stability Testing
Time frame: 4 months
Fabrication Efficacy -- Retention Trials Week 1
Time frame: 1 week
Fabrication Efficacy -- Retention Trials, Month 4
Time frame: 4 months
Fabrication Efficacy -- Tissue Adaptation, Palatal Rim. Number of Participants With Poor Adaptation
Time frame: Day of delivery
Fabrication Efficacy -- Tissue Adaptation, Facial Rim. Number of Participants With Poor Adaptation
Time frame: Day of Delivery
Fabrication Efficacy -- Tissue Adaptation, Number of Subjects Whose Splints Had Excessive Material
Time frame: Day of Delivery
Fabrication Efficacy -- Tissue Adaptation, Tightness. Number of Participants Reporting Excessive Tightness
Time frame: Day of Delivery
Fabrication Efficacy -- Oral Health Plaque Index
Time frame: 1 week and 4 months
Fabrication Efficacy -- Oral Health Modified Gingival Index
Time frame: 1 week and 4 months
Stability -- Splint Movement During Jaw Movement Tasks
Time frame: 4 months
Stability -- Number of Splints Dislodged by Clenching
Time frame: 4 months
Stability -- Number of Splints Dislodged by Grinding
Time frame: 4 Months
Stability -- Number of Splints Dislodged During Border Movement Trials
Time frame: 4 months
Stability -- Number of Splints Dislodged by Tapping
Time frame: 4 months
Stability -- Number of Splints Dislodged During Maximum Openings
Time frame: 4 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20370807Cunha-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.
- Background: PubMed 1298767Dworkin 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.
- Background: PubMed 20664825Fricton 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.
- Background: PubMed 21965492Gonzalez 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.
- Background: PubMed 17949541Huynh 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.
- Background: PubMed 20859563Klasser 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.
- Background: PubMed 23726332Lin 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.
- Background: PubMed 19788425Maeda 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.
- Background: PubMed 22938147Monse 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.
- Background: PubMed 18780535Ohrbach 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.
- Derived from this study: PubMed 32779386Gerstner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey Gerstner, DDS, MS, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOVA Bite Splint and Michigan Bite Splint in people with Sleep Bruxism and Tooth Wear, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Nights of Splint Wear for Four Months Per Subject. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02340663, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.