Occlusal Stabilization Splints and Sleep Disordered Breathing

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.

Study Overview

• Status: Withdrawn
• Conditions: Sleep Bruxism
• Intervention / Treatment: Device: Maxillary OSS; Device: Mandibular OSS; Device: Modified farrar splint

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maxillary OSS	Device: 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.
Experimental: Mandibular OSS	Device: 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.
Experimental: Modified farrar splint	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Aaron Glick, DDS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2022
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): July 1, 2023

Study Registration Dates

• First Submitted: September 1, 2019
• First Submitted That Met QC Criteria: September 1, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Stomatognathic Diseases; Parasomnias; Tooth Diseases; Sleep Apnea Syndromes; Bruxism; Sleep Bruxism
• Other Study ID Numbers: HSC-DB-19-0444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No