Occlusal Stabilization Splints and Sleep Disordered Breathing

Sleep Bruxism Clinical Trial

Official title:

Occlusal Stabilization Splints and Sleep Disordered Breathing

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04078074
• Other study ID #: HSC-DB-19-0444
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bruxism
• Sleep Apnea Syndromes
• Sleep Bruxism

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peripheral capillary oxygen saturation (SpO2) as measured by the MediByte device		Baseline(without device),with device
Primary	Change in pulse as measured by the MediByte device		Baseline(without device),with device
Primary	Change in airflow as measured by the MediByte device		Baseline(without device),with device
Primary	Change in chest plethysmography as measured by the MediByte device		Baseline(without device),with device
Primary	Change in abdomen plethysmography as measured by the MediByte device		Baseline(without device),with device
Primary	Change in masticatory muscle activity as measured by the MediByte device		Baseline(without device),with device
Secondary	Change in airway anatomy as measured by CBCT		Baseline(without device),with device