Occlusal Stabilization Splints and Sleep Disordered Breathing

NCT04078074 | Withdrawn FDA Device

• 1 other identifier: HSC-DB-19-0444
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Bruxism

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Change in airway anatomy as measured by CBCT

  Baseline(without device),with device

Study Arms (3)

Maxillary OSS

EXPERIMENTAL

Device: Maxillary OSS

Mandibular OSS

EXPERIMENTAL

Device: Mandibular OSS

Modified farrar splint

EXPERIMENTAL

Device: Modified farrar splint

Interventions

Maxillary OSS DEVICE

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.

Maxillary OSS

Mandibular OSS DEVICE

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.

Mandibular OSS

Modified farrar splint DEVICE

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.

Modified farrar splint

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with sleep bruxism
• prescribed an occlusal splint

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

MeSH Terms

Conditions

Sleep Bruxism

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Aaron Glick, DDS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 4, 2019
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share