Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery
Condition: Pain; Other Surgical Procedures; Impacted Third Molar Tooth; Cytochrome P450 CYP2C9 Enzyme Deficiency
MeSH terms: Tooth, Impacted
Intervention: Piroxicam
Intervention description: After extraction of at least one third molar, 100 patients will be treated with Piroxicam (20 mg once daily for 4 days) for pain control, collect the saliva to be genotyped and phenotyped for CYP2C9 (by PCR) and their post-operative notes (pain, swelling, trismus, temperature) will be analyzed. For the pharmacokinetics of piroxicam saliva samples will be collected from 10 of these patients at different times after ingestion of a capsule of 20 mg Piroxicam (before, 1, 2, 3, 4, 5, 6, 8, 11, 24, 48 and 72 hours after ingestion).
Intervention MeSH terms: Piroxicam
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 17 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Piroxicam; Pharmacogenetic; Lower Third molar

Summary:

      Pharmacogenetics is an area of Pharmacology that studies the contribution of genetic factors
      to individual responses to drugs. This branch of science involves the variability in
      pharmacodynamics and pharmacokinetics through the study of polymorphisms in genes encoding
      receptors, as well as in drug metabolism, where this area of Pharmacology has been growing
      and achieving its first results with clinical use. The non-steroidal anti-inflammatory
      (NSAIDS) are metabolized by cytochrome P450 (CYP) family, predominantly CYP2C9. The goal of
      this study is to evaluate the different gene haplotypes for the clinical efficacy of
      piroxicam after third lower molar surgery for pain, edema and trismus, adverse reactions,
      need of rescue medication, patient satisfaction regarding the drug and the pharmacokinetics
      of the drug between the different gene haplotypes for CYP2C9 that are found in this
      population. Therefore, 60 patients will be genotyped and phenotyped for this gene and their
      postoperative data will be confronted with the data found in the Brazilian population. For
      the analysis of the proposed gene, saliva will be collected and serve as a source of genomic
      DNA. For the molecular analysis, polymerase chain reaction (PCR) with tests validated and
      produced by Applied Biosystems® will be performed. For the pharmacokinetics, saliva samples
      will be collected at various times according to protocols available in the literature, and
      piroxicam concentrations in the samples will be measured by high pressure liquid
      chromatography (HPLC) and Liquid chromatography-mass spectrometry (LC MS/MS). The analysis of
      the results will be described with a significance level of 0.05.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Impacted lower third molar;

          -  not making use of nonsteroidal anti-inflammatory drugs in the last 7 days;

        Exclusion Criteria:

          -  Local anesthetics allergy;

          -  History of gastrointestinal bleeding or ulcers;

          -  Kidney disease;

          -  Asthma;

          -  Allergy or sensitivity to aspirin or any other anti-inflammatory non-steroid agent;

          -  Pregnant or nursing women;

          -  Patients using antidepressant, diuretic or aspirin;

          -  Patients received antibiotics for 30 days prior to surgery.