Temporomandibular Joint Disorders
Conditions
Interventions
The intervention was the drug type. The drug of interest was the beta-blocker Nadolol 40mg, compared to placebo control and a positive control Ibuprofen 400 mg. 84 participants composed the sample, 29
Drug
Sponsors
Fapesp - Fundação de Amparo à Pesquisa do Estado de São Paulo
Fapesp - Fundação de Amparo à Pesquisa do Estado de São Paulo
Eligibility
Age
18 Years to 48 Years
Inclusion criteria
Inclusion criteria: Men and women (using or not oral contraceptive), aged between 18 and 48 years and met Research Diagnostic Criteria for TMD (RDC/TMD) class I (muscle pain) and II (articular pain).
Exclusion criteria
Exclusion criteria: Self-reported osteoarthroses (RDC group IIIc), rheumatoid arthritis, fibromyalgia, trigeminal neuralgia, gynecological disorders (endometriosis), asthma, chronic lung disease, bronchospasm, renal, hepatic or cardiovascular diseases, nasal polyps, angioedema, reactivity to acetylsalicylic acid or other NSAIDs. Irregular menstrual cycles, use of hormonal replacement therapy, pregnancy or nursing, craniofacial trauma or surgery within the last 6 weeks, orthodontic treatment, and depression or other psychiatric conditions, seizures, drug abuse, current chemotherapy or radiation therapy; patients taking the following medications: drugs with central nervous system action (e.g., opioids, benzodiazepines, nonbenzodiazepine sedative hypnotics, selective serotonin reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors, and anticonvulsants) and ?-blockers. Medications for headaches (e.g. triptans) and NSAIDs were not allowed during the last two days before the study visits. Subjects with low heart rate (e.g. under 55 bpm) and diastolic blood pressure below 50 mmHg were excluded from the study to reduce the risk of an adverse hypotensive response to ?-blockade.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcomes: We hypothesized that one and three days of treatment with the nonselective beta-ARs antagonist nadolol would reduce clinical spontaneous and no spontaneous pain in Temporomandibular Dysfunction (TMD) patients significantly more than placebo. We further hypothesized that women would experience relatively greater benefit from nadolol than men depending on their hormonal status. Finally, because nonsteroidal anti-inflammatory drugs (NSAIDs) represent first-line drugs for many clinicians treating TMD pain, we also compared the effect of nadolol with the effect of the NSAID ibuprofen. The sample was calculated based on previous studies and considering a significance of 95%.;Outcomes effectively observed at the end of the study: One and three days treatment with nadolol (40 mg once a day) or ibuprofen (400 mg once a day) induces greater analgesia in TMD women and men than placebo. However, nadolol is more effective than ibuprofen and placebo in reducing no spontaneous pain in men and women since it induces a significantly greater maximum bite force increase. Women were more responsive to treatments than men independent of their menstrual cycle phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Our findings point out nadolol as a novel pharmacological option to treat TMD pain.;Considering that many patients are intolerant to prolonged treatment with NSAIDs and that not all TMD pain patients respond to its effects, we hypothesized that nadolol could decrease spontaneous and non-spontaneous pain in TMD patients. | — |
Countries
Brazil
Contacts
Public ContactNádia Cristina Fávaro Moreira
Unicamp
Outcome results
None listed