Temporomandibular Disorder (TMD) Pain in Response to Jaw Advancement in People With TMD and Obstructive Sleep Apnea

NCT02685202 | Terminated Results

• 1 other identifier: 16-4598
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myalgia; Apnea, Obstructive Sleep

Keywords

orofacial pain; sleep-disordered breathing; temporomandibular disorder; oral appliance; upper airway collapse

Outcome Measures

Primary Outcomes (1)

• Change in the Weekly Mean Pain Index Score

  Weekly mean pain index is computed as the arithmetic mean of daily pain index values recorded at enrollment and then at the end of each week throughout the 16 week observation period. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") multiplied by pain duration (0-100 percentage scale) where percentage refers to the percent of waking day that the participant had facial pain) as reported in the Daily Symptom Diary. It is computed from the weekly mean pain index (numeric rating scale 0-10), and representing the arithmetic mean of daily pain index values in the preceding 7-day period. The pain index for any given day is the product of the pain intensity score multiplied by the pain duration score, each as reported in the Daily Symptom Diary kept by the subject.

  Baseline, 16 weeks

Secondary Outcomes (2)

• Change in the Apnea Hypopnea Index (AHI)

  Baseline, 16 weeks

• Change in the Epworth Sleepiness Scale (ESS) Score

  Baseline, 16 weeks

Study Arms (1)

Mandibular advancement splint

EXPERIMENTAL

An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position

Device: Mandibular advancement splint

Interventions

Mandibular advancement splint DEVICE

A mandibular advancement splint (MAS), functions by comfortably positioning the patient's mandibular in a forward position, clearing the obstructed airway during sleep.

Mandibular advancement splint

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

MeSH Terms

Conditions

Myalgia; Sleep Apnea, Obstructive; Facial Pain; Sleep Apnea Syndromes; Temporomandibular Joint Disorders

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Joint Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Limitations and Caveats

All nine subjects were lost to follow-up during the 16-week observation period.

Results Point of Contact

• Title: Anne E. Sanders, PhD
• Organization: University of North Carolina at Chapel Hill

anne_sanders@unc.edu

919-537-3275

Study Officials

• Anne E Sanders, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 18, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 14, 2017
• Results First Posted: November 14, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share