Evaluation of the Effect of Antibiotic Prophylaxis (2g Amoxicillin One Hour Before Surgery) on an Inflammatory Factor (PGE2) in Salivary Samples After Third Molars Surgery

Universidad Católica San Antonio de Murcia

Status and phase: Completed; Phase 4

Conditions: Healthy; Amoxicillin; Third Molar Extraction Surgery; Antibiotic Prophylaxis

Treatments: Drug: Placebo; Drug: Amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT06613776

CE032315

Details and patient eligibility

About

This clinical trial aims to evaluate the impact of antibiotics on inflammation and pain in patients who have undergone mandibular third molar surgery. The primary research questions are:

1. Do antibiotics reduce pain following third molar surgery?
2. Do antibiotics influence facial swelling and the patient's ability to open their mouth?
3. Do antibiotics affect the levels of a specific inflammatory marker in saliva post-surgery?

Participants will be randomly assigned to receive either antibiotic capsules or placebo capsules. The study will include the following procedures:

Medication: Participants will take four capsules (either antibiotics or placebo) as part of their standard surgical care.

Saliva Samples: Saliva samples will be collected at three time points: before surgery, 24 hours after surgery, and 7 days post-surgery.

Measurements: Facial swelling and mouth opening will be assessed by the investigator at each time point.

By comparing the outcomes between the antibiotic and placebo groups, researchers aim to determine the effectiveness of antibiotics in managing post-surgical inflammation and pain.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy people (ASA I & II)
• Older than 18 years
• No history of viral or microbial diseases during the last four months
• No history of allergic reaction to penicillin-class antibiotics or other drugs that will be used during the research
• No history of anti-inflammatory or contraceptive drugs use during the last month
• Not being in pregnancy or nursing period for women
• Having at least one unerupted mandibular wisdom tooth needs surgical intervention

Exclusion criteria

• History of dental pain, inflammation, or abscess during the last month
• thyroid hormone therapy
• unwillingness to participate in the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

intervention group (Antibiotic)

Experimental group

Description:

4 amoxicillin 500 mg capsules (2 grams)

Treatment:

Drug: Amoxicillin

Control group (Placebo)

Placebo Comparator group

Description:

4 empty amoxicillin 500mg capsules

Treatment:

Drug: Placebo