Temporomandibular Disorder (TMD) Pain in Response to Jaw Advancement in People With TMD and Obstructive Sleep Apnea
Myalgia, Apnea, Obstructive Sleep
About this trial
This is an interventional treatment trial for Myalgia focused on measuring orofacial pain, sleep-disordered breathing, temporomandibular disorder, oral appliance, upper airway collapse
Eligibility Criteria
Inclusion Criteria:
- Any race or ethnicity
- Meet Research Diagnostic Criteria for TMD to confirm Group II: Masticatory Muscle Disorders, 1A: Myalgia
- Rate their TMD pain severity as ≥4 on a 0-10 numeric rating scale
- Have no history of treatment for OSA.
If taking a prescription medication (with the exception of prescription formulations of NSAIDs, acetaminophen, and aspirin) episodically for the management of pain, the subject must agree to discontinue its use prior to or at the baseline visit. If taking a prescription medication daily for the management of pain, must agree to continue the daily use of the medication throughout the 16-week observation period. If taking an over-the-counter pain medication daily, the subject must agree to continue the daily use throughout the study.
Exclusion Criteria:
- <8 retained teeth per arch
- Tooth mobility
- Unmanaged periodontal disease
- Skeletal Class III occlusion
- Central sleep apnea
- Hypoventilation syndromes
- Congestive heart failure
- Chronic obstructive pulmonary disease.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Mandibular advancement splint
An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position