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| Name | Class |
|---|---|
| Universitat Internacional de Catalunya | OTHER |
| Hospital Odontològic UB | OTHER |
| Hospital Universitario La Fe | OTHER |
| Hospital Universitario Rey Juan Carlos |
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The objetive of this study is to explore the efficacy and safety of a triple combination of ibuprofen, magnesium and ascorbic acid for acute pain treatment in TMJD patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple combination | Experimental | Powder for oral administration |
|
| Ibuprofen | Active Comparator | Powder for oral administration |
|
| Magnesium + ascorbic acid | Active Comparator | Powder for oral administration |
|
| Placebo | Placebo Comparator | Powder for oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug |
| ||
| Magnesium |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level from baseline compared to placebo assessed by a pain VAS scale | Pain level is measured according to visual analogue scale (VAS, 0-100 mm) before and 7 days after treatment. | seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline compared to placebo assessed by RDC/TMD questionnaire at day 3 +/-1 and at day 7. | seven days |
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Inclusion Criteria:
Exclusion Criteria:
Patients who are pregnant or breastfeeding.
Patients who have a consumption of enzyme-inducing drugs within the 30 days prior to the study: carbamazepinam, nevirapine, phenobarbital, rifampin, secobarbital and St. John's wort.
Patients who are consuming: acetaminophen, acetyl salicylic acid, bemiparina, clonixidina, oral anticoagulant, heparin and derivatives, systemic corticosteroids, pemetresed, digoxin, phenytoin, lithium, methotrexate, Salicylates, NSAIDs, antacids containing aluminum, such as algeldrato, magaldrate, morphine and its derivatives.
Patients who have been medicated with NSAIDs or Morphic derivatives for the treatment of pain of TMD prior to attending the consultation will be included whether, they meet a washout period of 8 to 12 hours (depending on the medication taken) before being included in the study.
Patients with underlying systemic pathology candidate to receive drug treatment with analgesic.
In patients with a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs. Peptic ulcer / active or recurrent gastrointestinal hemorrhage (two or more episodes of ulceration) or proven hemorrhage.
Patients with active Ulcerative colitis or Crohn's disease. Severe heart failure. Severe renal dysfunction. Severe hepatic dysfunction.
Patients with urolithiasis by oxalate
History of alcoholism or drug dependence within 3 months prior to the screening visit, and / or, History of psychotropic drugs consumption within 3 months prior to the screening visit.
Heavy consumer of stimulating beverages (>5 coffees, teas, or cola drinks per day).
History of drug allergy, idiosyncrasy or hypersensitivity. 11 Patients with cerebrovascular bleeding or other active bleeding 12 Patients with bleeding diathesis or other bleeding disorders .
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| Name | Affiliation | Role |
|---|---|---|
| Giner Lluis, MD | Clinica Universitaria Odontologica de la Universidad Internacional de Cataluña | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Odontològic de la Universitat de Barcelona | Barcelona | Barcelona | 08027 | Spain | ||
| Clinica Universitaria Odontològica de la Universitat Internacional de Catalunya |
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| OTHER |
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|
| Ascorbic Acid | Drug |
|
| Placebo | Drug |
|
| Sant Cugat del Vallès |
| Barcelona |
| 08195 |
| Spain |
| Hospital Universitario Rey Juan Carlos | Móstoles | Madrid | 28933 | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D008274 | Magnesium |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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