Trial Outcomes & Findings for Nocturnal Mouth Guards, SOVA vs. Standard Acrylic Orthotic; Phase IV (NCT NCT02340663)

NCT ID: NCT02340663

Last Updated: 2018-07-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 67 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2018-07-09

Participant Flow

104 individuals screened, 81 met criteria

14 individuals dropped out prior to group assignment during consent process due to time/scheduling issues

Participant milestones

Measure	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 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 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
Overall Study STARTED	35	32
Overall Study Clinical Exam, Impressions	35	32
Overall Study Splint Delivery, Assessments	33	31
Overall Study 1 Week Follow-up, Assessments	33	31
Overall Study 4 Month Follow-up, Assessments	30	31
Overall Study COMPLETED	30	31
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Measure	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 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 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
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	SOVA Bite Splint n=35 Participants 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 n=32 Participants 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 n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=93 Participants	32 Participants n=4 Participants	67 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	25.5 Years STANDARD_DEVIATION 3.33 • n=93 Participants	25.4 Years STANDARD_DEVIATION 3.83 • n=4 Participants	25.5 Years STANDARD_DEVIATION 3.55 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	15 Participants n=4 Participants	34 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	17 Participants n=4 Participants	33 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=93 Participants	30 Participants n=4 Participants	61 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	26 Participants n=93 Participants	23 Participants n=4 Participants	49 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	35 Participants n=93 Participants	32 Participants n=4 Participants	67 Participants n=27 Participants
Bruxing Self-report < 1 night / month	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Bruxing Self-report 1-3 nights / month	6 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants
Bruxing Self-report 1 -3 nights / week	15 Participants n=93 Participants	14 Participants n=4 Participants	29 Participants n=27 Participants
Bruxing Self-report 4 - 7 nights / week	13 Participants n=93 Participants	14 Participants n=4 Participants	27 Participants n=27 Participants

PRIMARY outcome

Timeframe: 4 months

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

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=31 Participants 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
Total Number of Nights of Splint Wear for Four Months Per Subject.	93.6 nights Standard Deviation 31.62	98.7 nights Standard Deviation 41.13

SECONDARY outcome

Timeframe: 4 months

Population: 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.

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.

Outcome measures

Measure	SOVA Bite Splint n=25 Participants 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 n=28 Participants 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
Number of Bruxing Events Per Hour Sleep Per Night.	52.9 muscle bursts / hour Standard Deviation 27.15	41.5 muscle bursts / hour Standard Deviation 25.11

SECONDARY outcome

Timeframe: 4 months

Population: 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.

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.

Outcome measures

Measure	SOVA Bite Splint n=27 Participants 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 n=30 Participants 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
Splint Material Loss / 4 Months.	-0.20 millimeters Standard Deviation 0.170	-0.17 millimeters Standard Deviation 0.234

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=31 Participants 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
Compliance -- Appliance Removal at Night	1.2 Units on a scale Standard Deviation 1.40	0.8 Units on a scale Standard Deviation 1.19

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=31 Participants 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
Compliance -- Use of Alternative Devices	0.6 Units on a scale Standard Deviation 1.30	0.5 Units on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: 4 months

Population: Mandibular models were not available for two SOVA patients.

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.

Outcome measures

Measure	SOVA Bite Splint n=28 Participants 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 n=31 Participants 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
Functional Efficacy -- Tooth Wear	-.060 millimeters Standard Deviation 0.013	-.053 millimeters Standard Deviation 0.013

SECONDARY outcome

Timeframe: 4 months

Population: Question not answered by one SOVA participant.

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.

Outcome measures

Measure	SOVA Bite Splint n=29 Participants 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 n=31 Participants 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
Functional Efficacy -- Alteration of Bruxism Habit, Self Report of Reduced Bruxism	2.7 Units on a scale Standard Deviation 1.00	3.0 Units on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=31 Participants 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
Functional Efficacy -- Alteration of Bruxism Habit, Self-Report of Muscle Relaxation	1.9 Units on a scale Standard Deviation 0.94	2.5 Units on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: On day of delivery

Population: 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.

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.

Outcome measures

Measure	SOVA Bite Splint n=29 Participants 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 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
User Satisfaction -- Ease of Fabrication Strongly disagree	1 Participants	—
User Satisfaction -- Ease of Fabrication Somewhat disagree	3 Participants	—
User Satisfaction -- Ease of Fabrication Neither agree nor disagree	1 Participants	—
User Satisfaction -- Ease of Fabrication Somewhat agree	13 Participants	—
User Satisfaction -- Ease of Fabrication Strongly agree	11 Participants	—

SECONDARY outcome

Timeframe: On day of delivery

Population: 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.

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.

Outcome measures

Measure	SOVA Bite Splint n=29 Participants 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 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
User Satisfaction -- Ease of Instructions Strongly disagree	0 Participants	—
User Satisfaction -- Ease of Instructions Somewhat disagree	1 Participants	—
User Satisfaction -- Ease of Instructions Neither agree nor disagree	2 Participants	—
User Satisfaction -- Ease of Instructions Somewhat agree	16 Participants	—
User Satisfaction -- Ease of Instructions Strongly agree	10 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=31 Participants 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
User Satisfaction -- Self-Report of Splint Fit	3.1 Units on a scale Standard Deviation 1.23	3.3 Units on a scale Standard Deviation 0.83

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=31 Participants 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
Fabrication Efficacy -- Estimated Bite Forces During Stability Testing Group Means	28.4 kilograms Standard Deviation 1.13	16.7 kilograms Standard Deviation 1.09
Fabrication Efficacy -- Estimated Bite Forces During Stability Testing Border	24.4 kilograms Standard Deviation 1.14	11.7 kilograms Standard Deviation 1.11
Fabrication Efficacy -- Estimated Bite Forces During Stability Testing Clench	49.7 kilograms Standard Deviation 1.14	35.5 kilograms Standard Deviation 1.11
Fabrication Efficacy -- Estimated Bite Forces During Stability Testing Grind Lateral	17.7 kilograms Standard Deviation 1.14	10.4 kilograms Standard Deviation 1.10
Fabrication Efficacy -- Estimated Bite Forces During Stability Testing Grind Protrusive	25.4 kilograms Standard Deviation 1.15	12.3 kilograms Standard Deviation 1.11
Fabrication Efficacy -- Estimated Bite Forces During Stability Testing Tap	34.1 kilograms Standard Deviation 1.14	24.4 kilograms Standard Deviation 1.11

SECONDARY outcome

Timeframe: 1 week

Population: Data not available for one SOVA participant.

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.

Outcome measures

Measure	SOVA Bite Splint n=29 Participants 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 n=31 Participants 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
Fabrication Efficacy -- Retention Trials Week 1	1.1 Occurrences Standard Deviation 1.93	0.6 Occurrences Standard Deviation 1.69

SECONDARY outcome

Timeframe: 4 months

Population: Data not available for one SOVA participant.

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.

Outcome measures

Measure	SOVA Bite Splint n=29 Participants 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 n=31 Participants 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
Fabrication Efficacy -- Retention Trials, Month 4	1.7 Number of occurrences out of 40. Standard Deviation 3.42	0.6 Number of occurrences out of 40. Standard Deviation 1.86

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=31 Participants 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
Fabrication Efficacy -- Tissue Adaptation, Palatal Rim. Number of Participants With Poor Adaptation	7 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=31 Participants 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
Fabrication Efficacy -- Tissue Adaptation, Facial Rim. Number of Participants With Poor Adaptation	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=31 Participants 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
Fabrication Efficacy -- Tissue Adaptation, Number of Subjects Whose Splints Had Excessive Material	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=31 Participants 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
Fabrication Efficacy -- Tissue Adaptation, Tightness. Number of Participants Reporting Excessive Tightness	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=31 Participants 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
Fabrication Efficacy -- Oral Health Plaque Index Lingual Upper, Month 4	0.29 proportion of total regions Standard Deviation 0.109	0.28 proportion of total regions Standard Deviation 0.108
Fabrication Efficacy -- Oral Health Plaque Index Group Means	0.39 proportion of total regions Standard Deviation 0.019	0.38 proportion of total regions Standard Deviation 0.019
Fabrication Efficacy -- Oral Health Plaque Index Buccal Upper, Week 1	0.46 proportion of total regions Standard Deviation 0.187	0.42 proportion of total regions Standard Deviation 0.165
Fabrication Efficacy -- Oral Health Plaque Index Buccal Upper, Month 4	0.46 proportion of total regions Standard Deviation 0.163	0.38 proportion of total regions Standard Deviation 0.155
Fabrication Efficacy -- Oral Health Plaque Index Buccal Lower, Week 1	0.41 proportion of total regions Standard Deviation 0.187	0.43 proportion of total regions Standard Deviation 0.147
Fabrication Efficacy -- Oral Health Plaque Index Buccal Lower, Month 4	0.37 proportion of total regions Standard Deviation 0.135	0.39 proportion of total regions Standard Deviation 0.125
Fabrication Efficacy -- Oral Health Plaque Index Lingual Upper, Week 1	0.31 proportion of total regions Standard Deviation 0.173	0.31 proportion of total regions Standard Deviation 0.174
Fabrication Efficacy -- Oral Health Plaque Index Lingual Lower, Week 1	0.39 proportion of total regions Standard Deviation 0.127	0.44 proportion of total regions Standard Deviation 0.169
Fabrication Efficacy -- Oral Health Plaque Index Lingual Lower, Month 4	0.39 proportion of total regions Standard Deviation 0.142	0.41 proportion of total regions Standard Deviation 0.138

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=31 Participants 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
Fabrication Efficacy -- Oral Health Modified Gingival Index Buccal Upper, Week 1	0.96 Units on a scale Standard Deviation 0.628	0.92 Units on a scale Standard Deviation 0.673
Fabrication Efficacy -- Oral Health Modified Gingival Index Buccal Upper, Month 4	1.02 Units on a scale Standard Deviation 0.757	1.00 Units on a scale Standard Deviation 0.747
Fabrication Efficacy -- Oral Health Modified Gingival Index Buccal Lower, Week 1	0.87 Units on a scale Standard Deviation 0.542	0.92 Units on a scale Standard Deviation 0.643
Fabrication Efficacy -- Oral Health Modified Gingival Index Buccal Lower, Month 4	0.99 Units on a scale Standard Deviation 0.713	0.95 Units on a scale Standard Deviation 0.746
Fabrication Efficacy -- Oral Health Modified Gingival Index Lingual Upper, Week 1	0.88 Units on a scale Standard Deviation 0.610	0.86 Units on a scale Standard Deviation 0.67
Fabrication Efficacy -- Oral Health Modified Gingival Index Lingual Upper, Month 4	0.95 Units on a scale Standard Deviation 0.722	0.91 Units on a scale Standard Deviation 0.644
Fabrication Efficacy -- Oral Health Modified Gingival Index Lingual Lower, Week 1	1.09 Units on a scale Standard Deviation 0.679	1.03 Units on a scale Standard Deviation 0.696
Fabrication Efficacy -- Oral Health Modified Gingival Index Lingual Lower, Month 4	1.08 Units on a scale Standard Deviation 0.748	0.98 Units on a scale Standard Deviation 0.726
Fabrication Efficacy -- Oral Health Modified Gingival Index Group Means	0.93 Units on a scale Standard Deviation 0.04	0.89 Units on a scale Standard Deviation 0.039

SECONDARY outcome

Timeframe: 4 months

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

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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=30 Participants 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
Stability -- Splint Movement During Jaw Movement Tasks Clenching	0.72 millimeters Standard Deviation 1.938	0.71 millimeters Standard Deviation 1.583
Stability -- Splint Movement During Jaw Movement Tasks Grinding	0.83 millimeters Standard Deviation 1.660	0.78 millimeters Standard Deviation 0.697
Stability -- Splint Movement During Jaw Movement Tasks Border Movements	0.63 millimeters Standard Deviation 1.238	1.12 millimeters Standard Deviation 1.331
Stability -- Splint Movement During Jaw Movement Tasks Tapping	0.33 millimeters Standard Deviation 0.412	0.30 millimeters Standard Deviation 0.361
Stability -- Splint Movement During Jaw Movement Tasks Maximum Opening	1.16 millimeters Standard Deviation 0.940	1.60 millimeters Standard Deviation 1.298
Stability -- Splint Movement During Jaw Movement Tasks Resting	0.16 millimeters Standard Deviation 0.177	0.22 millimeters Standard Deviation 0.225
Stability -- Splint Movement During Jaw Movement Tasks Group Means	0.65 millimeters Standard Deviation 1.257	0.78 millimeters Standard Deviation 1.143

SECONDARY outcome

Timeframe: 4 months

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

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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=30 Participants 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
Stability -- Number of Splints Dislodged by Clenching < 1 mm	26 Participants	27 Participants
Stability -- Number of Splints Dislodged by Clenching 1 - 2 mm	2 Participants	1 Participants
Stability -- Number of Splints Dislodged by Clenching 2 - 3 mm	1 Participants	1 Participants
Stability -- Number of Splints Dislodged by Clenching > 6 mm	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 Months

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

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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=30 Participants 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
Stability -- Number of Splints Dislodged by Grinding < 1 mm	26 Participants	23 Participants
Stability -- Number of Splints Dislodged by Grinding 1 - 2 mm	3 Participants	4 Participants
Stability -- Number of Splints Dislodged by Grinding 2 - 3 mm	0 Participants	2 Participants
Stability -- Number of Splints Dislodged by Grinding 3 - 4 mm	0 Participants	1 Participants
Stability -- Number of Splints Dislodged by Grinding > 6 mm	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 months

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

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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=30 Participants 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
Stability -- Number of Splints Dislodged During Border Movement Trials < 1 mm	28 Participants	20 Participants
Stability -- Number of Splints Dislodged During Border Movement Trials 1 - 2 mm	0 Participants	5 Participants
Stability -- Number of Splints Dislodged During Border Movement Trials 2 - 3 mm	1 Participants	2 Participants
Stability -- Number of Splints Dislodged During Border Movement Trials 3 - 4 mm	0 Participants	1 Participants
Stability -- Number of Splints Dislodged During Border Movement Trials 4 - 5 mm	0 Participants	1 Participants
Stability -- Number of Splints Dislodged During Border Movement Trials 5 - 6 mm	0 Participants	1 Participants
Stability -- Number of Splints Dislodged During Border Movement Trials > 6 mm	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 months

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

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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=30 Participants 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
Stability -- Number of Splints Dislodged by Tapping < 1 mm	28 Participants	28 Participants
Stability -- Number of Splints Dislodged by Tapping 1 - 2 mm	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 4 Months

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

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.

Outcome measures

Measure	SOVA Bite Splint n=30 Participants 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 n=30 Participants 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
Stability -- Number of Splints Dislodged During Maximum Openings < 1 mm	18 Participants	13 Participants
Stability -- Number of Splints Dislodged During Maximum Openings 1 - 2 mm	7 Participants	8 Participants
Stability -- Number of Splints Dislodged During Maximum Openings 2 - 3 mm	2 Participants	2 Participants
Stability -- Number of Splints Dislodged During Maximum Openings 3 - 4 mm	3 Participants	5 Participants
Stability -- Number of Splints Dislodged During Maximum Openings 4 - 5 mm	0 Participants	2 Participants

Adverse Events

SOVA Bite Splint

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Michigan Bite Splint

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SOVA Bite Splint n=35 participants at risk 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 n=32 participants at risk 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
Skin and subcutaneous tissue disorders Skin Rash	0.00% 0/35 • 4 months Each participant was followed for four months.	3.1% 1/32 • Number of events 1 • 4 months Each participant was followed for four months.
Metabolism and nutrition disorders Mucosal Bleeding Spot	0.00% 0/35 • 4 months Each participant was followed for four months.	3.1% 1/32 • Number of events 1 • 4 months Each participant was followed for four months.
General disorders Tooth Chipped	0.00% 0/35 • 4 months Each participant was followed for four months.	3.1% 1/32 • Number of events 1 • 4 months Each participant was followed for four months.

Additional Information

Dr. Geoffrey Gerstner

University of Michigan

Phone: 734-763-7717

Email: geger@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place