Exploratory Study To Assess the Efficacy and Safety of a Triple Combination for Acute Pain Treatment in Patients With Temporomandibular Joint Disorders (TMJD).

Study Overview
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Brief Summary
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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

Official Title
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Randomized, Double Blind, Placebo Controlled Exploratory Study To Assess the Efficacy and Safety of a Triple Combination of Ibuprofen+Mg+Ascorbic Acid for Acute Pain Treatment in Temporomandibular Join Disorder (TMJD) Patients

Conditions
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Temporomandibular Joint Disorders

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Magnesium
* Drug: Ascorbic Acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: TMD dysfunction syndrome patients of RDC/TMD Groups Ia and/or Ib (+/- IIIa and/or IIIb); with moderate to severe pain (VAS >4), refractory to conservative treatment (including splint / local prosthesis) Subjects between 18 and 65 years. Body weight within the normal range (IMC index between 19 and 30) expressed as weight (kg) /height (m2). Physical condition according to ASA I or II (American Society of Anesthesiologists) Having not participated in previous clinical trial during the three months preceding the setting-up of this study. Free acceptance to collaborate in the study, expressed by signature of written informed consent by the participant 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 .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triple combination<br>Powder for oral administration | Drug: Ibuprofen<br> <br> Drug: Magnesium<br> <br> Drug: Ascorbic Acid<br> <br> |
| Active Comparator: Ibuprofen<br>Powder for oral administration | Drug: Ibuprofen<br> <br> |
| Active Comparator: Magnesium + ascorbic acid<br>Powder for oral administration | Drug: Magnesium<br> <br> Drug: Ascorbic Acid<br> <br> |
| Placebo Comparator: Placebo<br>Powder for oral administration | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporomandibular, joint, pain, ibuprofen, magnesium, vitamin C