Occlusal Stabilization Splints and Sleep Disordered Breathing

The University of Texas System (UT)

Status: Withdrawn

Conditions: Sleep Bruxism

Treatments: Device: Modified farrar splint; Device: Mandibular OSS; Device: Maxillary OSS

Study type: Interventional

Funder types: Other

Identifiers

NCT04078074

HSC-DB-19-0444

Details and patient eligibility

About

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.

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Maxillary OSS

Experimental group

Treatment:

Device: Maxillary OSS

Mandibular OSS

Experimental group

Treatment:

Device: Mandibular OSS

Modified farrar splint

Experimental group

Treatment:

Device: Modified farrar splint