RecruitingPhase 4ACTRN12619000149167

Antibiotic efficacy when extracting lower third molars

Preoperative and postoperative antibiotic prophylaxis efficacy against placebo when extracting impacted mandibular third molars


Sponsor

María del Mar Mariscal Cazalla

Enrollment

90 participants

Start Date

May 7, 2018

Study Type

Interventional

Conditions

Summary

Due to the current increase of bacterial resistance to antibiotics, our main objective is to assess whether the use of an antibiotic for the extraction of a retained mandibular third molar is really useful in reducing the risk of infection. In this study we will compare the infection, inflammation and pain in patients who have taken different antibiotic treatments and patients who have not taken any antibiotics. Our study hypothesis is that in healthy patients won't be necessary any antibiotic treatment for the extraction of a third molar without infection, so that we can reduce the consumption of antibiotics and the presence of bacterial resistances.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Removing an impacted wisdom tooth (lower third molar) is one of the most common dental procedures. Antibiotics are often prescribed to prevent infection after the extraction, but with bacterial resistance to antibiotics becoming an increasing global concern, it is important to question whether antibiotics are actually needed in healthy patients. This study compares outcomes in patients who receive different antibiotic regimens versus no antibiotics after wisdom tooth removal. Participants are healthy adults having their lower wisdom tooth extracted, randomly assigned to one of several groups. Researchers track infection rates, swelling, pain, and recovery over the following weeks. The hypothesis is that healthy patients do not need antibiotic prophylaxis, which would support reducing unnecessary antibiotic use. You may be eligible if you are aged 18 or older, are in good general health (classified as ASA I — no significant medical conditions), and need your lower wisdom tooth extracted. You are not eligible if you are pregnant or breastfeeding, have taken antibiotics in the week before surgery, have any known drug allergies relevant to the study medications, or have a systemic health condition.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Use of preoperative and postoperative antibiotic prophylaxis for the extraction of retained mandibular third molar. Patients will be divided in three groups. -Group 1: it will be formed by thirty pat

Use of preoperative and postoperative antibiotic prophylaxis for the extraction of retained mandibular third molar. Patients will be divided in three groups. -Group 1: it will be formed by thirty patients. They will be given one tablet of amoxicillin 750 mg each 8 hours. Patients will start the treatment two days before the extraction and will continue it until five days later. -Group 2: it will be formed by thirty patients. This group will take a placebo two days before the extraction and will take the same amoxicillin 750 mg treatment each 8 hours 5 days later. -Group 3: it will be formed by thirty patients too. They will be administrated placebo each 8 hours. Patients will start the treatment two days before the extraction and will continue it until five days later. The extractions will be made by students of the Master of Oral Surgery and Implantology in the University of Granada. For monitoring the intervention, the principal investigator will require drug tablet return 7 days after the extraction. The antibiotic and placebo tablets will have the same size and color. In this way, all patients (Group 1, 2 or 3) will start taking medication (placebo or antibiotic according to the group) two days before the tooth extraction and continue 5 days after


Locations(1)

Granada, Spain

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ACTRN12619000149167


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