Temporomandibular Disorder (TMD) Pain in Response to Jaw Advancement in People With TMD and Obstructive Sleep Apnea
Temporomandibular Disorder (TMD) Pain in Response to Jaw Advancement in People With TMD and Obstructive Sleep Apnea
The purpose of this study is to characterize the course of temporomandibular disorder (TMD)
 pain in adults with TMD and obstructive sleep apnea (OSA), all of whom are being treated with
 mandibular advancement splint (MAS) therapy.

 Study participants are 12 adults with painful TMD and comorbid mild to moderate OSA
 (apnea-hypopnea index ≥5 and <30).

 This is an interventional study in which 12 patients receive MAS therapy for comorbid TMD/OSA
 for 16 weeks. It is standard of care to treat mild or moderate OSA with MAS therapy, the the
 effect on MAS therapy on TMD pain in people with OSA is unknown. There is no comparison
 group. Care is being provided under the direction of a sleep physician by a dentist who
 specializes in dental sleep medicine. The investigators expect that as MAS therapy reduces
 the severity of OSA, painful TMD symptoms will also reduce.
Two chronic health conditions are treated with oral appliances during sleep. One condition is
 temporomandibular disorder (TMD); a musculoskeletal disorder characterized by pain in the
 masseter muscle and temporomandibular joint. TMD pain is treated with a stabilization splint
 which operates by limiting abnormal muscle activity. The other condition is obstructive sleep
 apnea (OSA). Mild to moderate OSA is treated with a mandibular advancement splint (MAS) which
 holds the mandible in a protruded position to increase the pharyngeal airway space and reduce
 upper airway collapsibility.

 The comorbidity of the two conditions is high. Approximately one in four patients with
 clinically diagnosed TMD has OSA diagnosed by polysomnogram (PSG). This comorbidity poses a
 problem for management because neither appliance is considered effective in treating both
 conditions. In fact, mandible advancement is assumed to worsen TMD pain. However this
 assumption is not well supported by scientific evidence, with some studies finding that
 mandibular advancement actually reduces TMD pain, albeit after a transient increase in TMD
 pain in some patients. Furthermore, anecdotal evidence suggests that mandibular advancement
 reduces TMD pain. It is believed that by maintaining an open airway with the oral appliance,
 patients no longer have to clench their teeth in an effort to prevent the airway from
 collapsing during sleep.

 The overall objective of this study is to characterize the temporal nature of TMD pain in
 adults with comorbid TMD/OSA treated with MAS therapy. It is the first study to monitor
 adherence to MAS therapy objectively in this study population, using a microsensor embedded
 in the MAS.

 Recruitment and MAS therapy will be conducted at Lane and Associates Family Dentistry; a
 group of 27 dental practices located throughout the Triangle and Triad region of North
 Carolina. Advantages of using Lane & Associates are: large influx of new dental patients
 every month, fast recruitment, well-established protocols for screening for TMD and OSA and
 for referral of patients to sleep physicians for evaluation and PSG, standardized protocols
 for oral appliance therapy, and a Dental Sleep Medicine director who is highly experienced
 also in the management of TMD. The study coordinator is a dental hygienist in the University
 of North Carolina (UNC) School of Dentistry Dental Sleep Clinic who works in the School's
 Dental Sleep Medicine practice. She will travel to the Lane & Associates offices to assist in
 clinical and administrative activities and will manage all data collection for the 12
 subjects. The Dental Sleep Clinic at the UNC School of Dentistry is not considered adequate
 to serve as the study site because it currently operates only one day a week and accepts
 referrals for only patients without TMD pain.

 In the pre-enrollment phase, patients at Lane and Associates Family Dentistry will complete a
 standard TMD screening questionnaire. Those screening positive will be clinically examined
 against Research Diagnostic Criteria for TMD to confirm Group II: Masticatory Muscle
 Disorders, 1A: Myalgia. They will also be screened for OSA using the validated STOP-BANG
 questionnaire. Those at high risk will be referred for evaluation by a sleep physician and a
 diagnostic PSG, as is the standard of care at Lane and Associates. If the PSG reveals mild to
 moderate OSA (apnea-hypopnea index (AHI) ≥5 and <30), the patient is a candidate for oral
 appliance therapy, pending confirmation of the sleep physician, and thus eligible to enroll
 in the study.

 Subjects will be consented and assessed for demographics, medical history, and medication
 use. Impressions of the upper and lower dental arches will be recorded, poured in dental
 stone and sent to the lab. A George Gauge will record a protrusive bite registration with the
 jaw advanced 60% from the most retruded position. The custom-made MAS will be fitted with a
 micro-recorder (Braebon DentiTrac Monitor) to assess adherence. The investigators define
 adherence as use of the splint 4 hours/night for ≥70% of nights as is standard practice for
 continuous positive airway pressure (CPAP) therapy. Home sleep test (HST): Subjects will
 complete a series (from 2 to 5) two-night home sleep tests (HSTs) using the portable AccuSom
 device by NovaSom, which collects sleep parameters of AHI, minimum oxygen saturation, and
 snoring indices. Novosom arranges shipment of the device and offers 24-hour technical support
 during the sleep test. Sleep data are uploaded wirelessly from the recorder to an online
 portal for statistical analysis.

 Following a baseline home sleep test (HST), 12 participants will enter the study wearing a
 MAS during sleep that protrudes the mandible to 60% of its maximal advancement. This
 approximates the minimum amount of jaw advancement that is expected to be efficacious. A HST
 will be repeated at the end of Week #4. If that HST shows that the MAS is not efficacious
 (i.e. has not reduced baseline apnea hypopnea index (AHI) by ≥50% or the AHI is ≥10**), and
 if TMD pain is not worse, the mandible will be advanced to 70% and the participant will
 repeat the HST at the end of Week #8. Once efficacy is achieved, there is no need for further
 HSTs. If efficacy is not achieved at the end of Week #8 and if TMD pain is not worse, the
 mandible will be advanced to 75% and the participant will repeat the HST at the end of Week
 #12. If efficacy is not yet achieved and if TMD pain is not worse, the mandibular will be
 further advanced to 80% and the participant will undergo a final HST at the end of Week #16.
 Once a HST indicates that the MAS is efficacious in reducing the AHI, the participant will
 maintain that level of advancement. The minimum number of HSTs for any one participant is 2
 (baseline and 4-week follow-up) and the maximum number is 5.
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.