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Functional, psychosocial and related to the sleep effects of different therapies in TMD: randomized clinical trial

Functional, psychosocial and related to the sleep effects of different therapies in temporomandibular dysfunctions: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6vyb3f
Enrollment
Unknown
Registered
2019-03-07
Start date
2017-07-12
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Temporomandibular joint disorders

Interventions

Interventions: occlusal splint, counseling, Occlusal splint associated with counseling and physiotherapy. Each group will consist of 30 individuals, which will generate a total of 120 subjects in the
Device
Behavioural
Other
E02.779

Sponsors

Departamento de Odontologia da Universidade Federal do Rio Grande do Norte
Lead Sponsor
Departamento de Odontologia da Universidade Federal do Rio Grande do Norte
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Positive diagnosis for TMD performed through RDC / TMD (Research Diagnostic Criteria for Temporomandibular Disorders)(DWORKIN; LERESCHE, 1992); last treatment for TMD with a minimum interval of 3 months; report of pain in the orofacial region in the last 3 months.

Exclusion criteria

Exclusion criteria: Impairment of cognitive ability, being unable to understand the questionnaires questions; history of head trauma related to the etiology of orofacial pain confusing the TMD diagnosis; intracranial disorders or headache; use of medications in the last 3 months that interfere with sleep quality such as muscle relaxants, anticonvulsants, antidepressants and anxiolytics; use of medication to treat TMD or muscle pain; other causes of orofacial pain such as caries, periodontal diseases, or neuropathies and fibromyalgia. pregnant or lactating patients, in recovery from myocardial infarction, or cardiac arrhythmias, congestive heart failure, cardiac block, or other conduction problems.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Reduced levels of anxiety (measured by HADS, BAI and IDATE). To verify the improvement of the outcome through the results of the HADS, BAI and IDATE questionnaires after therapy with the different study groups (occlusal splint, counseling, occlusal splint associated with counseling and physiotherapy). Reduced levels of anxiety for normal anxiety or a significant reduction of values. For HADS and BAI it is 0 to 7; for the IDATE is 20-30.;Expected outcome 2: Reduction of depression levels (measured by BDI and HADS). To verify the improvement of the outcome through the results of the BDI and HADS questionnaires after therapy with the different treatment groups (occlusal splint, counseling, occlusal splint associated with counseling and physiotherapy). Reduction of depression levels to levels considered normal by the reference values of the questionnaires or a significant reduction. For HADS and BDI it is 0 to 7 points.;Expected outcome 3: improvement of function (measured by ITM). To verify reestablishment of the function through the temporomandibular index results after therapy with the different treatment groups (occlusal splint, counseling, occlusal splint associated with counseling and physiotherapy). Improvement of function according to index criteria in the functional, muscular and articular levels.;Expected outcome 4: Reduction of pain (measured by EVA). Check the reduction of the pain chart through the visual analog pain scale. For an improvement observe a reduction of 30% of the initial value after therapy with the different study groups (occlusal splint, counseling, occlusal splint associated with counseling and physiotherapy).;Expected outcome 5: Improvement of quality of life (measured by World Health Organization Quality of Life - WHOQOL and Oral Health Organization 14 - OHIP). To verify the improvement of the outcome through the results of the WHOQOL and OHIP questionnaires after therapy with the different treatment groups (occlusal sp

Secondary

MeasureTime frame
Improvement in anxiety (measured by BDI and HADS), function (measured by ITM), pain (measured by VAS), quality of life (measured by WHOQOL and OHIP) and (Measured by the Pittsburgh questionnaire) in TMD patients after association of differents therapies, after 6 months of therapy.

Countries

Brazil

Contacts

Public ContactGustavo Barbosa

Departamento de Odontologia da Universidade Federal do Rio Grande do Norte

gustavoaseabra@hotmail.com+558499852201

Outcome results

None listed

Source: REBEC (via WHO ICTRP)