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

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02340663
• Collaborator: Delta Dental Fund of Michigan (Other)
• Enrollment: 67
• Location: 1
• Arms: 2
• Duration (Months): 18.3
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Bruxism; Tooth Wear	Device: SOVA Bite Splint; Device: Michigan Bite Splint	N/A

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

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Preliminary Phase IV Trial Comparing the SOVA Night Guard With the Clinical Standard Acrylic Orthotic
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: May 10, 2017
• Actual Study Completion Date: May 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SOVA bite splint 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; Over-the-counter thermoplastic bite splint blank, heated, molded to fit.
Active Comparator: Michigan Bite Splint 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; Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit

Outcome Measures

Primary Outcome Measures

1. Total Number of Nights of Splint Wear for Four Months Per Subject. [4 months]

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

Secondary Outcome Measures

1. Number of Bruxing Events Per Hour Sleep Per Night. [4 months]

   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.

2. Splint Material Loss / 4 Months. [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.

3. Compliance -- Appliance Removal at Night [4 months]

   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.

4. Compliance -- Use of Alternative Devices [4 months]

   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.

5. Functional Efficacy -- Tooth Wear [4 months]

   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.

6. Functional Efficacy -- Alteration of Bruxism Habit, Self Report of Reduced Bruxism [4 months]

   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.

7. Functional Efficacy -- Alteration of Bruxism Habit, Self-Report of Muscle Relaxation [4 months]

   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.

8. User Satisfaction -- Ease of Fabrication [On day of delivery]

   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.

9. User Satisfaction -- Ease of Instructions [On day of delivery]

   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.

10. User Satisfaction -- Self-Report of Splint Fit [4 months]

    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.

11. Fabrication Efficacy -- Estimated Bite Forces During Stability Testing [4 months]

    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.

12. Fabrication Efficacy -- Retention Trials Week 1 [1 week]

    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.

13. Fabrication Efficacy -- Retention Trials, Month 4 [4 months]

    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.

14. Fabrication Efficacy -- Tissue Adaptation, Palatal Rim. Number of Participants With Poor Adaptation [Day of delivery]

    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.

15. Fabrication Efficacy -- Tissue Adaptation, Facial Rim. Number of Participants With Poor Adaptation [Day of Delivery]

    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.

16. Fabrication Efficacy -- Tissue Adaptation, Number of Subjects Whose Splints Had Excessive Material [Day of Delivery]

    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.

17. Fabrication Efficacy -- Tissue Adaptation, Tightness. Number of Participants Reporting Excessive Tightness [Day of Delivery]

    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.

18. Fabrication Efficacy -- Oral Health Plaque Index [1 week and 4 months]

    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.

19. Fabrication Efficacy -- Oral Health Modified Gingival Index [1 week and 4 months]

    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.

20. Stability -- Splint Movement During Jaw Movement Tasks [4 months]

    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.

21. Stability -- Number of Splints Dislodged by Clenching [4 months]

    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.

22. Stability -- Number of Splints Dislodged by Grinding [4 Months]

    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.

23. Stability -- Number of Splints Dislodged During Border Movement Trials [4 months]

    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.

24. Stability -- Number of Splints Dislodged by Tapping [4 months]

    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.

25. Stability -- Number of Splints Dislodged During Maximum Openings [4 Months]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan School of Dentistry	Ann Arbor	Michigan	United States	48109-1078

Sponsors and Collaborators

• University of Michigan
• Delta Dental Fund of Michigan

Investigators

• Principal Investigator: Geoffrey Gerstner, DDS, MS, PhD, University of Michigan

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 10, 2015

More Information

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

• Responsible Party: Geoffrey E. Gerstner, Associate Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT02340663
• Other Study ID Numbers: HUM00085489
• First Posted: Jan 16, 2015
• Last Update Posted: Jul 9, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by Geoffrey E. Gerstner, Associate Professor, University of Michigan: dental orthotic; bite splint; oral parafunction; clenching; grinding
• Additional relevant MeSH terms: Bruxism; Sleep Bruxism; Tooth Wear

Study Results

Participant Flow

Recruitment Details	104 individuals screened, 81 met criteria
Pre-assignment Detail	14 individuals dropped out prior to group assignment during consent process due to time/scheduling issues

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Period Title: Overall Study
STARTED	35	32
Clinical Exam, Impressions	35	32
Splint Delivery, Assessments	33	31
1 Week Follow-up, Assessments	33	31
4 Month Follow-up, Assessments	30	31
COMPLETED	30	31
NOT COMPLETED	5	1

Baseline Characteristics

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint	Total
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit	Total of all reporting groups
Overall Participants	35	32	67
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	35 100%	32 100%	67 100%
>=65 years	0 0%	0 0%	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	25.5 (3.33)	25.4 (3.83)	25.5 (3.55)
Sex: Female, Male (Count of Participants)
Female	19 54.3%	15 46.9%	34 50.7%
Male	16 45.7%	17 53.1%	33 49.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 8.6%	1 3.1%	4 6%
Not Hispanic or Latino	31 88.6%	30 93.8%	61 91%
Unknown or Not Reported	1 2.9%	1 3.1%	2 3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 3.1%	1 1.5%
Asian	7 20%	5 15.6%	12 17.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 5.7%	2 6.3%	4 6%
White	26 74.3%	23 71.9%	49 73.1%
More than one race	0 0%	1 3.1%	1 1.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	35 100%	32 100%	67 100%
Bruxing Self-report (Count of Participants)
< 1 night / month	1 2.9%	0 0%	1 1.5%
1-3 nights / month	6 17.1%	4 12.5%	10 14.9%
1 -3 nights / week	15 42.9%	14 43.8%	29 43.3%
4 - 7 nights / week	13 37.1%	14 43.8%	27 40.3%

Outcome Measures

1. Primary Outcome

Title	Total Number of Nights of Splint Wear for Four Months Per Subject.
Description	Count of the total number of entire nights that subjects wore the splint provided to them in the study.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	31
Mean (Standard Deviation) [nights]	93.6 (31.62)	98.7 (41.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.23
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Number of Bruxing Events Per Hour Sleep Per Night.
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Polysomnographic data were not available from 5 SOVA and 3 Michigan splint subjects due to data corruption. Corruption typically occurs when a subject either removes the device or an electrode while sleeping, or the recorded data are too noisy to analyze due to electronic interference while the subject is asleep.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	25	28
Mean (Standard Deviation) [muscle bursts / hour]	52.9 (27.15)	41.5 (25.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.045
	Comments
	Method	ANOVA
	Comments

3. Secondary Outcome

Title	Splint Material Loss / 4 Months.
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Three SOVA subjects and 1 Michigan subject were not included in the analysis, because the scanned models could not be successfully aligned. This was likely due to a warpage of the impressions taken, warpage in the stone models that were scanned, or error in the model scanning process.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	27	30
Mean (Standard Deviation) [millimeters]	-0.20 (0.170)	-0.17 (0.234)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.665
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Compliance -- Appliance Removal at Night
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	31
Mean (Standard Deviation) [Units on a scale]	1.2 (1.40)	0.8 (1.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.249
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Compliance -- Use of Alternative Devices
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	31
Mean (Standard Deviation) [Units on a scale]	0.6 (1.30)	0.5 (1.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.626
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Functional Efficacy -- Tooth Wear
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Mandibular models were not available for two SOVA patients.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	28	31
Mean (Standard Deviation) [millimeters]	-.060 (0.013)	-.053 (0.013)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.695
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Functional Efficacy -- Alteration of Bruxism Habit, Self Report of Reduced Bruxism
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Question not answered by one SOVA participant.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	29	31
Mean (Standard Deviation) [Units on a scale]	2.7 (1.00)	3.0 (0.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.255
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Secondary Outcome

Title	Functional Efficacy -- Alteration of Bruxism Habit, Self-Report of Muscle Relaxation
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	31
Mean (Standard Deviation) [Units on a scale]	1.9 (0.94)	2.5 (1.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.049
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

Title	User Satisfaction -- Ease of Fabrication
Description	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.
Time Frame	On day of delivery

Outcome Measure Data

Analysis Population Description

One SOVA bite splint participant did not respond. Participants with the Michigan bite splint did not fabricate their splints; hence, this question is irrelevant to them.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	29	0
Strongly disagree	1 2.9%
Somewhat disagree	3 8.6%
Neither agree nor disagree	1 2.9%
Somewhat agree	13 37.1%
Strongly agree	11 31.4%

10. Secondary Outcome

Title	User Satisfaction -- Ease of Instructions
Description	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.
Time Frame	On day of delivery

Outcome Measure Data

Analysis Population Description

One SOVA bite splint participant did not respond to this question. Michigan bite splint participants did not fabricate their splints; hence, this question was irrelevant for them.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	29	0
Strongly disagree	0 0%
Somewhat disagree	1 2.9%
Neither agree nor disagree	2 5.7%
Somewhat agree	16 45.7%
Strongly agree	10 28.6%

11. Secondary Outcome

Title	User Satisfaction -- Self-Report of Splint Fit
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	31
Mean (Standard Deviation) [Units on a scale]	3.1 (1.23)	3.3 (0.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.750
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

12. Secondary Outcome

Title	Fabrication Efficacy -- Estimated Bite Forces During Stability Testing
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	31
Group Means	28.4 (1.13)	16.7 (1.09)
Border	24.4 (1.14)	11.7 (1.11)
Clench	49.7 (1.14)	35.5 (1.11)
Grind Lateral	17.7 (1.14)	10.4 (1.10)
Grind Protrusive	25.4 (1.15)	12.3 (1.11)
Tap	34.1 (1.14)	24.4 (1.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The P-value given is the computed value
	Method	Mixed Models Analysis
	Comments

13. Secondary Outcome

Title	Fabrication Efficacy -- Retention Trials Week 1
Description	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.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Data not available for one SOVA participant.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	29	31
Mean (Standard Deviation) [Occurrences]	1.1 (1.93)	0.6 (1.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.544
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

14. Secondary Outcome

Title	Fabrication Efficacy -- Retention Trials, Month 4
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Data not available for one SOVA participant.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	29	31
Mean (Standard Deviation) [Number of occurrences out of 40.]	1.7 (3.42)	0.6 (1.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.220
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

15. Secondary Outcome

Title	Fabrication Efficacy -- Tissue Adaptation, Palatal Rim. Number of Participants With Poor Adaptation
Description	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.
Time Frame	Day of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	31
Count of Participants [Participants]	7 20%	2 6.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.081
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

16. Secondary Outcome

Title	Fabrication Efficacy -- Tissue Adaptation, Facial Rim. Number of Participants With Poor Adaptation
Description	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.
Time Frame	Day of Delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	31
Count of Participants [Participants]	4 11.4%	4 12.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

17. Secondary Outcome

Title	Fabrication Efficacy -- Tissue Adaptation, Number of Subjects Whose Splints Had Excessive Material
Description	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.
Time Frame	Day of Delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	31
Count of Participants [Participants]	5 14.3%	4 12.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.731
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

18. Secondary Outcome

Title	Fabrication Efficacy -- Tissue Adaptation, Tightness. Number of Participants Reporting Excessive Tightness
Description	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.
Time Frame	Day of Delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	31
Count of Participants [Participants]	0 0%	3 9.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.238
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

19. Secondary Outcome

Title	Fabrication Efficacy -- Oral Health Plaque Index
Description	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.
Time Frame	1 week and 4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	31
Buccal Upper, Week 1	0.46 (0.187)	0.42 (0.165)
Buccal Upper, Month 4	0.46 (0.163)	0.38 (0.155)
Buccal Lower, Week 1	0.41 (0.187)	0.43 (0.147)
Buccal Lower, Month 4	0.37 (0.135)	0.39 (0.125)
Lingual Upper, Week 1	0.31 (0.173)	0.31 (0.174)
Lingual Upper, Month 4	0.29 (0.109)	0.28 (0.108)
Lingual Lower, Week 1	0.39 (0.127)	0.44 (0.169)
Lingual Lower, Month 4	0.39 (0.142)	0.41 (0.138)
Group Means	0.39 (0.019)	0.38 (0.019)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.952
	Comments	The P-value refers to the difference in group means, see "Group Means" row in the table.
	Method	ANOVA
	Comments

20. Secondary Outcome

Title	Fabrication Efficacy -- Oral Health Modified Gingival Index
Description	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.
Time Frame	1 week and 4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	31
Buccal Upper, Week 1	0.96 (0.628)	0.92 (0.673)
Buccal Upper, Month 4	1.02 (0.757)	1.00 (0.747)
Buccal Lower, Week 1	0.87 (0.542)	0.92 (0.643)
Buccal Lower, Month 4	0.99 (0.713)	0.95 (0.746)
Lingual Upper, Week 1	0.88 (0.610)	0.86 (0.67)
Lingual Upper, Month 4	0.95 (0.722)	0.91 (0.644)
Lingual Lower, Week 1	1.09 (0.679)	1.03 (0.696)
Lingual Lower, Month 4	1.08 (0.748)	0.98 (0.726)
Group Means	0.93 (0.04)	0.89 (0.039)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.53
	Comments	The P-value refers to the difference in group means, see "Group Means" row in the table.
	Method	ANOVA
	Comments

21. Secondary Outcome

Title	Stability -- Splint Movement During Jaw Movement Tasks
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Data not available for one participant in the Michigan bite splint treatment group.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	30
Clenching	0.72 (1.938)	0.71 (1.583)
Grinding	0.83 (1.660)	0.78 (0.697)
Border Movements	0.63 (1.238)	1.12 (1.331)
Tapping	0.33 (0.412)	0.30 (0.361)
Maximum Opening	1.16 (0.940)	1.60 (1.298)
Resting	0.16 (0.177)	0.22 (0.225)
Group Means	0.65 (1.257)	0.78 (1.143)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.292
	Comments	The P-value refers to the difference in group means, see "Group Means" row in the table.
	Method	Mixed Models Analysis
	Comments

22. Secondary Outcome

Title	Stability -- Number of Splints Dislodged by Clenching
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Data not available for one participant in the Michigan bite splint group

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	30
< 1 mm	26 74.3%	27 84.4%
1 - 2 mm	2 5.7%	1 3.1%
2 - 3 mm	1 2.9%	1 3.1%
> 6 mm	1 2.9%	1 3.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments	The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.289
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

23. Secondary Outcome

Title	Stability -- Number of Splints Dislodged by Grinding
Description	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.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

Data not available for one participant in the Michigan bite splint group.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	30
< 1 mm	26 74.3%	23 71.9%
1 - 2 mm	3 8.6%	4 12.5%
2 - 3 mm	0 0%	2 6.3%
3 - 4 mm	0 0%	1 3.1%
> 6 mm	1 2.9%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.287
	Comments	The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.
	Method	Wilcoxon (Mann-Whitney)
	Comments

24. Secondary Outcome

Title	Stability -- Number of Splints Dislodged During Border Movement Trials
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Data not available for one participant in the Michigan bite splint group.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	30
< 1 mm	28 80%	20 62.5%
1 - 2 mm	0 0%	5 15.6%
2 - 3 mm	1 2.9%	2 6.3%
3 - 4 mm	0 0%	1 3.1%
4 - 5 mm	0 0%	1 3.1%
5 - 6 mm	0 0%	1 3.1%
> 6 mm	1 2.9%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.505
	Comments	The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.
	Method	Wilcoxon (Mann-Whitney)
	Comments

25. Secondary Outcome

Title	Stability -- Number of Splints Dislodged by Tapping
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Data not available from one participant in the Michigan bite splint group.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	30
< 1 mm	28 80%	28 87.5%
1 - 2 mm	2 5.7%	2 6.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.643
	Comments	The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.
	Method	Wilcoxon (Mann-Whitney)
	Comments

26. Secondary Outcome

Title	Stability -- Number of Splints Dislodged During Maximum Openings
Description	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.
Time Frame	4 Months

Outcome Measure Data

Analysis Population Description

Data not available for one participant in the Michigan bite splint group.

Arm/Group Title	SOVA Bite Splint	Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of four months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
Measure Participants	30	30
< 1 mm	18 51.4%	13 40.6%
1 - 2 mm	7 20%	8 25%
2 - 3 mm	2 5.7%	2 6.3%
3 - 4 mm	3 8.6%	5 15.6%
4 - 5 mm	0 0%	2 6.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOVA Bite Splint, Michigan Bite Splint
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.923
	Comments	The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	4 months
Adverse Event Reporting Description	Each participant was followed for four months.
Arm/Group Title	SOVA Bite Splint		Michigan Bite Splint
Arm/Group Description	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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months. SOVA Bite Splint: Over-the-counter thermoplastic bite splint blank, heated, molded to fit.		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 4 months, dairy kept of nightly wear. Polysomnographic data obtained from one night at the end of three months. Michigan Bite Splint: Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
All Cause Mortality
	SOVA Bite Splint		Michigan Bite Splint
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/32 (0%)
Serious Adverse Events
	SOVA Bite Splint		Michigan Bite Splint
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	SOVA Bite Splint		Michigan Bite Splint
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		3/32 (9.4%)
General disorders
Tooth Chipped	0/35 (0%)	0	1/32 (3.1%)	1
Metabolism and nutrition disorders
Mucosal Bleeding Spot	0/35 (0%)	0	1/32 (3.1%)	1
Skin and subcutaneous tissue disorders
Skin Rash	0/35 (0%)	0	1/32 (3.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.