Clinical trial NCT04182191: Influence of CYP2C9 Genotype on Clinical Efficacy of Tenoxicam
Official title: Influence of Cytochrome P450 (CYP2C9) Genotype on Clinical Efficacy of Tenoxicam After Lower Third Molars Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Molar, Third
Pain
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to evaluate the different gene haplotypes for the clinical efficacy of tenoxicam 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

Detailed description: 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 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 tenoxicam 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, 100 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. 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.

Primary outcomes:
measure: Change of pain measured by visual analogue scale on periods of 0, 025, 05, 0,75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours after surgery.
timeFrame: Three days after surgery
Secondary outcomes:
measure: Adverse effects
timeFrame: Seven days after surgery
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Paulo Zupelari Goncalves, DDS, Ms
role: PRINCIPAL_INVESTIGATOR
References: