Sleep Bruxism
Conditions
Brief summary
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.
Interventions
DEVICEMaxillary OSS
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.
DEVICEMandibular OSS
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.
DEVICEModified farrar splint
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in airflow as measured by the MediByte device | Baseline(without device),with device |
| 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 masticatory muscle activity 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 |
Secondary
| Measure | Time frame |
|---|---|
| Change in airway anatomy as measured by CBCT | Baseline(without device),with device |
Outcome results
None listed