Craniomandibular Disorder. Temporomandibular Joint Disorders. Temporomandibular Joint Disorder Syndrome
Conditions
Interventions
Women over the age of 18 diagnosed with muscularTMD using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) instrument. The inclusion criteria are: pain intensity of at least 4 on the v
MT1.388.585
MT1.388.585.520
D27.505.954.427.700.122.055
MT1.388.585.520.110
Sponsors
Núcleo de Pesquisa e Desenvolvimento de Medicamentos
Núcleo de Pesquisa e Desenvolvimento de Medicamentos
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women; over 18 years of age; diagnosed with painful Temporomandibular Dysfunction of the muscular or mixed type; who report pain of intensity at least 4 on the numerical pain scale (NDS); for at least 3 months
Exclusion criteria
Exclusion criteria: other orofacial pain; smokers; presence of gingivitis with spontaneous bleeding; periodontitis; oral lesions; diseases affecting the adrenal glands; pregnant and lactating women; use of glucocorticoids and medications and/or supplements that affect cortisol levels less than 3 months before inclusion in the study (anticonvulsants; tricyclic antidepressants and/or monoamine oxidase inhibitors; estrogen receptor antagonists; antifungals; progesterone antagonists; diuretics; opioid analgesics and immunosuppressants); total edentulousness and partial edentulousness with presence of free end; refusal to sign the informed consent form; physical or psychological alterations that prevent the use of the assessment instruments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the end of the interventions (8 weeks), it is expected that there will be a decrease of at least 2 points in pain intensity as measured by the Numerical Pain Scale (NPS) and a decrease of at least 1 point in pain interference with work, daily and leisure activities as measured by the Pain Gradation Scale whose final score ranges from 0 to 6. The NPS and Pain Gradation Scale will also be used at the 3-month and 6-month post-intervention follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality will be assessed using the Pittsburg Sleep Quality Index (PSQI). Each of the 7 components of the PSQI ranges from 0-3: subjective quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, medication use and daily dysfunction. The sum of the 7 components ranges from 0-21. Higher scores indicate poorer sleep quality. A decrease in the total score is expected, indicating an improvement in sleep quality at the end of the interventions (8 weeks);Evaluate morning and evening salivary cortisol levels before and after the interventions (8 weeks). The levels considered normal are: less than 0.75 µg/ml for morning cortisol and less than 0.24 µg/ml for evening cortisol. Correlate with pain intensity, chronic pain classification, sleep quality, anxiety level, depression level, and mandibular disability;Depression is assessed using the Patient Health Questionnaire-9 (PHQ-9) scale, with scores ranging from 0 to 20. Higher scores indicate more severe depression. A decrease in PHQ-9 scores is expected at the end of the interventions (8 weeks).;Anxiety will be assessed using the GAD-7 (General Anxiety Disorder-7) instrument, whose scores range from 0 to 15. Higher scores indicate higher levels of anxiety. A decrease in GAD-7 scores is expected at the end of the interventions (8 weeks);Stress levels are assessed using the Patient Health Questionnaire-4 (PHQ-4) scale. Higher scores indicate higher levels of stress. A decrease in the score on this scale is expected at the end of the intervention (8 weeks);The level of somatization will be assessed using the PHQ-15 (Patient Health Questionnaire-15) scale. Higher scores indicate higher levels of somatization. A decrease in the PHQ-15 score is expected after the interventions (8 weeks);Mandibular disability is assessed using the 8-item Jaw Functional Limitation Scale (JFLS), which is part of Axis II of the DC/TMD (Diagnostic Criteria for Temporomandibular Disorder). An average score is calculated for all | — |
Countries
Brazil
Contacts
Public ContactErika Citó
Núcleo de Pesquisa e Desenvolvimento de Medicamentos
Outcome results
None listed