Occlusal Stabilization Splints and Sleep Disordered Breathing
NCT ID: NCT04078074
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-07-01
2023-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Maxillary OSS
Maxillary 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.
Mandibular OSS
Mandibular 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.
Modified farrar splint
Modified 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.
Interventions
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Maxillary 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.
Mandibular 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.
Modified 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.
Eligibility Criteria
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Inclusion Criteria
* prescribed an occlusal splint
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Aaron Glick
Clinical Assistant Professor
Principal Investigators
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Aaron Glick, DDS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Other Identifiers
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HSC-DB-19-0444
Identifier Type: -
Identifier Source: org_study_id
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