Occlusal Stabilization Splints and Sleep Disordered Breathing

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of mandibular occlusal stabilization splint (OSS) and modified farrar splint on sleep bruxism and respiratory indices and the effects of occlusal splints on the airway volume through imaging.

Official Title
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Occlusal Stabilization Splints and Sleep Disordered Breathing

Conditions
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Sleep Bruxism

Intervention / Treatment
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* Device: Maxillary OSS
* Device: Mandibular OSS
* Device: Modified farrar splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with sleep bruxism prescribed an occlusal splint Exclusion Criteria: Less than 18 years old Secondary obstructive sleep apnea diagnosis Genetic disease that contributes to possible secondary obstructive sleep apnea Patient refuses to sign informed consent document Patient does not speak or read English More than two missing posterior teeth (excluding third molars) Presence of gross malocclusion

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maxillary OSS<br> | Device: Maxillary OSS<br>* Maxillary OSS will be a night guard for the top teeth. Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep.This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo cone beam computed tomography (CBCT) airway imaging with and without splint.<br>|
| Experimental: Mandibular OSS<br> | Device: Mandibular OSS<br>* Mandibular OSS will be a night guard for the bottom teeth.Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep.This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo CBCT airway imaging with and without splint.<br>|
| Experimental: Modified farrar splint<br> | Device: Modified farrar splint<br>* Modified farrar splint will be a night guard for the top teeth that positions and maintains the lower jaw in a more forward position.Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep. This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo CBCT airway imaging with and without splint.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peripheral capillary oxygen saturation (SpO2) as measured by the MediByte device |  | Baseline(without device),with device | 
| Change in pulse as measured by the MediByte device |  | Baseline(without device),with device | 
| Change in airflow as measured by the MediByte device |  | Baseline(without device),with device | 
| Change in chest plethysmography as measured by the MediByte device |  | Baseline(without device),with device | 
| Change in abdomen plethysmography as measured by the MediByte device |  | Baseline(without device),with device | 
| Change in masticatory muscle activity as measured by the MediByte device |  | Baseline(without device),with device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in airway anatomy as measured by CBCT |  | Baseline(without device),with device |