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Myogenous temporomandibular disorders (TMD), I. physiotherapy compared with occlusal splint therapy, and II. occlusal adjustment compared with occlusal splint therapy combined with occlusal adjustment, using therapy-and-patient-specific treatment durations

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17469828
Enrollment
100
Registered
2016-11-11
Start date
1993-09-01
Completion date
Unknown
Last updated
2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic orofacial pain Oral Health Temporomandibular joint dysfunction

Interventions

For group I as well as group II, treatment outcome of the first type of therapy (physiotherapy or OA respectively) is evaluated in comparison to that of the second type of therapy (solely splint thera

Sponsors

University Medical Centre Utrecht
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Number of visits/duration of treatment used 2. Success rate based on post-treatment TDC 3. Effectiveness based on post-treatment TDC While number of visits/duration of treatment are known at the end of treatment, success rate and effectiveness are determined following treatment, i.e. after 4 weeks, 6 months and 12 months.

Secondary

MeasureTime frame
1. Predominant pain intensity of the masticatory system, , scored on a 100 mm Visual Analogue Scale (VAS) at the initial visit with diagnosis (4 weeks before the start of treatment), at the start of treatment, and following treatment, i.e. after 4 weeks, 6 months and 12 months Added 07/12/2016: 2. Mean actual pain intensity, scored on 100 mm VASs for 13 facial areas and 11 non-facial areas (neck and shoulder areas) which are depicted on illustrations of head, neck and shoulders from both sides of the body. These illustrations and VASs are included in the Pain Location Questionnaire 3. General Health-related Quality of Life, measured using utility values of Euroqol-5D (EQ-5D) Both measured at the start of treatment, and following treatment, i.e. after 4 weeks, 6 months and 12 months

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026