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Influence of gene P450 (CYP2C9) on clinical efficacy and pharmacokinetics of Piroxicam after third molar surgery

Influence of genotype of cytochrome P450 (CYP2C9) on clinical efficacy and pharmacokinetics of Piroxicam after lower third molar surgery - : Influence of CYP2C9 on clinical efficacy Piroxicam after third molar surgeries

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-6qgc6m
Enrollment
Unknown
Registered
2019-11-13
Start date
2013-10-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomatognathic diseases. Pathological conditions, signs and symptoms. Other specified disorders of teeth and supporting structures

Interventions

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 (
Drug
Procedure/surgery
E06.892
G02.111.325.500
D02.886.665.500

Sponsors

Faculdade de Odontologia de Bauru
Lead Sponsor
Faculdade de Odontologia de Bauru
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers of both genders; between 18 and 60 years; are not making use of nonsteroidal anti-inflammatory drugs in the last 7 days.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Expected outcome: Reduction of consumption of rescue medication associated with piroxicam use in mutated patients for CYP2C9, as assessed by the information contained in the patient's record sheet for the seven-day postoperative period.;Outcome found: Consumption rescue medication associated with the use of piroxicam was the same among patients mutated or not mutated for CYP2C9, evaluated the information contained in the patient's notes sheet as the postoperative period of seven days.

Secondary

MeasureTime frame
Expected Outcome: Increased reports of adverse effects in patients mutated during the postoperative period until suture removal seven days after extraction of the included and / or impacted third molar, assessed through the information contained in the patient's chart and records.;Outcome found: Absence of severe adverse effects reports for all patients, mutated or not to CYP2C9 during the postoperative period until suture removal seven days after extraction of third molar included and / or impacted, assessed by the information contained in the medical records and records of the patient.

Countries

Brazil

Contacts

Public ContactAdriana;Adriana Calvo;Calvo

Faculdade de Odontologia de Bauru;Faculdade de Odontologia de Bauru

dricalvo@usp.br;dricalvo@usp.br551432358276;551432358282

Outcome results

None listed

Source: REBEC (via WHO ICTRP)