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Evaluation of the effect of the drug Ketorolac Trometamol compared with physiotherapy treatment in patients with temporomandibular dysfunctio

Not Applicable
Recruiting
Conditions
Temporomandibular joint disorders
Facial pain
C23.888.592.612.330
K07.6
Registration Number
RBR-5wsz24
Lead Sponsor
niversidade Federal do Ceará
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

Patients of both sexes, from 18 to 50 years old;
Diagnosis of Temporomandibular Joint / Muscular Dysfunction (TMD), with pain for at least 60 or 90 days, confirmed after clinical evaluation by a dental professional;
Patient examined and considered in good health, according to medical judgment, without severe comorbidities; Patient is able to understand the nature and purpose of the study, including the risks and adverse effects and with the intention to cooperate with the researcher and to act in accordance with the requirements of the entire protocol, which is confirmed by signing the Terms of Reference. Informed Consent, performed before any procedure.

Exclusion Criteria

Patient has known hypersensitivity to non-steroidal anti-inflammatory drugs or a history of serious adverse reactions to any medicinal product. Body mass index (BMI) less than 18 or greater than 30; Current or recent history (within the last 12 months) of drug, drug or alcohol abuse; He was hospitalized for any reason for four weeks prior to the start of the study; Patients with a clinical history of serious heart, kidney, liver and lung disorders; Pregnant and / or nursing women; Patient undergoing specific treatment (orthodontic) for TMD at least 02 months; Patient using any medication with analgesic and / or anti-inflammatory action that cannot be suspended during the wash out period, which corresponds to 5 times the half-life of the drug; Participation in any experimental study or ingestion of any experimental drug three months prior to commencement of this study; EVA less than 05; Has any condition that the investigator deems relevant for non-participation in the study.

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The effectiveness of pharmacological treatment with Ketorolac will be assessed by pain improvement, measured by mean change in Visual Analog Pain Scale (VAS) score between baseline (V0), on the third day (V2) and after 5 days of treatment. (V3), compared between the four groups<br><br>
Secondary Outcome Measures
NameTimeMethod
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