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Clinical Trials/NCT04078074
NCT04078074
Withdrawn
Not Applicable

Occlusal Stabilization Splints and Sleep Disordered Breathing

ConditionsSleep Bruxism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Bruxism
Sponsor
The University of Texas Health Science Center, Houston
Primary Endpoint
Change in abdomen plethysmography as measured by the MediByte device
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
July 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aaron Glick

Clinical Assistant Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in abdomen plethysmography as measured by the MediByte device

Time Frame: Baseline(without device),with device

Change in peripheral capillary oxygen saturation (SpO2) as measured by the MediByte device

Time Frame: Baseline(without device),with device

Change in masticatory muscle activity as measured by the MediByte device

Time Frame: Baseline(without device),with device

Change in chest plethysmography as measured by the MediByte device

Time Frame: Baseline(without device),with device

Change in pulse as measured by the MediByte device

Time Frame: Baseline(without device),with device

Change in airflow as measured by the MediByte device

Time Frame: Baseline(without device),with device

Secondary Outcomes

  • Change in airway anatomy as measured by CBCT(Baseline(without device),with device)

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