ISRCTN17469828CompletedNot Applicable
Group I: Towards an optimal therapy strategy for myogenous temporomandibular disorders (TMD), physiotherapy compared with occlusal splint therapy in an RCT with therapy-and-patient-specific treatment durations Group II: Towards an optimal therapy strategy for myogenous temporomandibular disorders (TMD),occlusal adjustment compared to a combination of occlusal splint therapy and occlusal adjustment in an RCT with therapy-and-patient-specific treatment durations
niversity Medical Centre Utrecht0 sites100 target enrollmentStarted: November 11, 2016Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Age between 18 and 65 years
- •2. Female or male
- •3. Pain and tenderness of the masticatory muscles (in the absence of Temporomandibular Joint pathology, solely myogenous TMD), of 3 months duration or longer
- •4. A good understanding of Dutch
- •Added 07/12/2016:
- •5. Only for group II: Pronounced occlusal interferences, i.e. (i) a forward sliding of at least 2 mm and/or lateral sliding of at least 1 mm with respect to centric occlusion; and (ii) an interference on the non-active side that is not accompanied with contact on the active side
- •6. Only for group II: Feasibility of occlusal adjustment by grinding in a conservative way; assessment by mounting the patient’s dental casts in a semi-adjustable articulator
Exclusion Criteria
- •1. Clinical and/or radiographic evidence of organic changes in the temporomandibular Joints
- •2. Previous treatment with an occlusal stabilization appliance, occlusal adjustment, or physiotherapy of the masticatory system
- •3. Other treatments for pain (also nonfacial pain) more recent than a year
- •4. Predominant craniovertebral dysfunction (pain of neck and/or shoulders that predominates that of facial areas)
- •5. Metabolic, neurologic, vascular disease, or disorders (eg, diabetes, neuralgia, migraine)
- •6. Recent dramatic life event (divorce, bereavement, physical abuse by partner, incest, and victim of criminal assault) and/or psychotherapy and/or use of psycho-medication
- •7. Odd sleep/wake cycles due to work shift
- •8. Gross anomalies of the natural dentition: full/partial denture, loss of dorsal support, collapsed bite, extensive migrations, or morphological malocclusion (eg, cross bite)
- •9. Only for group I: Pronounced occlusal interferences, i.e. (i) ) a forward sliding of at least 2 mm and/or lateral sliding of at least 1 mm with respect to centric occlusion; and (2) an interference on the non-active side that is not accompanied with contact on the active side
Investigators
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