Treatment of temporomandibular disorders with non-invasive interventions Oral Health
Conditions
Interventions
The patients will be randomized using a computer-generated random allocation sequence into 3 different groups:
Group 1: Combined regimen with Orthotic splint therapy AND home care instructions
Group 2
Sponsors
Rutgers, The State University of New Jersey
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with TMD based on DC/TMD criteria with symptoms consistent with myalgia, myofascial pain with/without a referral, arthralgia and/or a combination of the above 2. Pain present for at least 3 months 3. 18-80 years old 4. Male/Female 5. Patients should have functional occlusion with posterior teeth support.
Exclusion criteria
Exclusion criteria: 1. The presence of comorbid systemic disease which can alter pain perception such as generalized muscle/joint or chronic pain disorders such as fibromyalgia, rheumatoid arthritis, Lyme disease, Osteoarthritis, idiopathic condylar resorption. 2. Subjects using chronic pain medications. 3. Subjects with cognitive problems that can result in an inability to follow instructions. If the patient has any disorders such as Down's syndrome or Alzheimer disease will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain levels measured using a Visual Analogue Scale (VAS) at Baseline (V0) and all follow up visits at 2 weeks, 4 weeks, 6 weeks and 3 months (V1, V2, V3, V4) 2. Masticatory muscle pain measured using (Temporalis and Masseter) Diagnostic Criteria/ Temporomandibular Disorder (DC/TMD) Protocol at Baseline (V0) and all follow up visits at 2 weeks, 4 weeks, 6 weeks and 3 months (V1, V2, V3, V4) 3. Temporomandibular joint pain measured using Diagnostic Criteria/ Temporomandibular Disorder (DC/ TMD) Protocol at Baseline (V0) and all follow up visits at 2 weeks, 4 weeks, 6 weeks and 3 months (V1, V2, V3, V4) 4. Mandibular range of motion (pain-free mouth opening, active and passive range of motion) measured using Diagnostic Criteria/ Temporomandibular Disorder (DC/ TMD) Protocol at Baseline (V0) and all follow up visits at 2 weeks, 4 weeks, 6 weeks and 3 months (V1, V2, V3, V4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Rescue medication use measured using Rescue medication questionnaire at all follow up visits, 2 weeks, 4 weeks, 6 weeks and 3 months (V1, V2, V3, V4) | — |
Countries
United States of America
Contacts
Public ContactGary;Cibele Heir;Nasri-Heir
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Outcome results
None listed