Occlusal Stabilization Splints and Sleep Disordered Breathing

Not Applicable

Withdrawn

• Conditions: Sleep Bruxism
• Interventions: Device: Modified farrar splint; Device: Mandibular OSS; Device: Maxillary OSS

• Registration Number: NCT04078074
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-01
• Study First Submitted QC: 2019-09-01
• Study First Posted: 2019-09-04
• Study Start: 2022-07-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified farrar splint	Modified farrar splint	-
Mandibular OSS	Mandibular OSS	-
Maxillary OSS	Maxillary OSS	-

Primary Outcome Measures

Name	Time	Method
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 peripheral capillary oxygen saturation (SpO2) 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 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

Secondary Outcome Measures

Name	Time	Method
Change in airway anatomy as measured by CBCT	Baseline(without device),with device