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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-05

Study Completion Date

2024-07-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Third Molar Extraction Surgery Antibiotic Prophylaxis Amoxicillin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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intervention group (Antibiotic)

4 amoxicillin 500 mg capsules (2 grams)

Group Type EXPERIMENTAL

Amoxicillin

Intervention Type DRUG

4 capsules of amoxicillin 500mg, 2 grams in total, one hour before surgery

Control group (Placebo)

4 empty amoxicillin 500mg capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

4 empty capsules of amoxicillin 500mg (placebo), one hour before surgery

Interventions

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Amoxicillin

4 capsules of amoxicillin 500mg, 2 grams in total, one hour before surgery

Intervention Type DRUG

Placebo

4 empty capsules of amoxicillin 500mg (placebo), one hour before surgery

Intervention Type DRUG

Eligibility Criteria

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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