NCT03169127

Clinical Pharmacogenetic of Ibuprofen After Lower Third Molar Surgeries

Clinical Pharmacogenetic of Ibuprofen Enantiomers After Lower Third Molar Surgeries

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The present clinical trial randomized will be to assess the link between the different haplotypes of CYP2C8 and CYP2C9 genes and the clinical efficacy of ibuprofen after lower third molar extractions. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 200 healthy volunteers underwent removal of one lower third molar, under local anesthesia with articaine 4% (1:200,000 adrenaline) will be genotyped and phenotyped for these genes and their postoperative records with all data collected will be compared with the haplotypes found in the Brazilian population.

Detailed description

The aim of this study will be to assess the link between the different haplotypes of CYP2C8 and CYP2C9 genes and the clinical efficacy of ibuprofen after lower third molar extractions regarding pain, swelling and trismus, adverse reactions, the amount of pain medication used, the patient satisfaction with the drug and the influence of the ability on preoperative modulation of conditioned pain. We will evaluate also the relationship between the different haplotypes of OPRM1 gene (SNP A118G), the salivary concentrations of pro-inflammatory cytokines (IL-2, IL-4, IL-6, IL-10 and TNF-±), and preoperative conditioned pain modulation. Therefore, 200 patients will be genotyped and phenotyped for these genes and their postoperative records with all data collected will be compared with the haplotypes found in the Brazilian population. For analysis of the proposed genes, saliva will be collected, which will serve as a source of genomic DNA. For molecular analysis it will be performed polymerase chain reaction (PCR). All tests will be conducted and validated by Applied Biosystems®. Also it will be held in the research, genetic sequencing of the genes CYP2C8, CYP2C9 and OPRM1, to verify possible correlations of these genes with postoperative pain and pain modulation.

Conditions

• Pain
• Other Surgical Procedures
• Impacted Third Molar Tooth

Interventions

Type	Name	Description
DRUG	Ibuprofen 600 mg	After lower third molars surgeries, pharmacogenetic and clinical efficacy of Ibuprofen 600mg was study.

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-07-30
• Completion: 2020-07-01
• First posted: 2017-05-30
• Last updated: 2019-07-12

Locations

1 site across 1 country: Brazil