Occlusal Stabilization Splints and Sleep Disordered Breathing

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 1, 2023

Interventions

  • 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.
  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Maxillary OSS
  • Experimental: Mandibular OSS
  • Experimental: Modified farrar splint

Clinical Trial Outcome Measures

Primary Measures

  • Change in peripheral capillary oxygen saturation (SpO2) 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
  • Change in chest plethysmography as measured by the MediByte device
    • Time Frame: Baseline(without device),with device
  • Change in abdomen plethysmography 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Provider of Information About this Clinical Study
    • Principal Investigator: Aaron Glick, Clinical Assistant Professor – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Aaron Glick, DDS, Principal Investigator, The University of Texas Health Science Center, Houston

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