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Clinical Trials/ACTRN12617001498381
ACTRN12617001498381
Completed
Phase 4

Antibiotic Prophylaxis in the prevention of infectious complications in mandibular impacted third molars extraction: A randomized clinical trial

Facultad de Odontología. Universidad de Chile0 sites120 target enrollmentOctober 24, 2017

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Facultad de Odontología. Universidad de Chile
Enrollment
120
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Background: The objective of this study was to determine the effect of antibiotic prophylaxis in preventing postoperative infections after extraction of impacted mandibular third molars. Material and Methods: A Parallel-group, randomized, blind, placebo-controlled trial was performed. 154 patients were randomly allocated to 2 groups; experimental (n=77) receiving 2g amoxicillin 1 hour prior to surgery and control (n=77) receiving placebo. The primary outcome was postoperative infections, and the secondary outcome was the need for rescue analgesia. Results: 4.5% of patients developed postoperative infections, five patients of the control group (4 alveolar osteitis, 1 surgical site infection) and two of the experimental group (1 alveolar osteitis, 1 surgical site infection). The difference between groups was not statistically significant, RR=0.4 (95%CI 0.08-1.99, p=0.41) NNTB=26. Rescue analgesia intake was significantly higher in the control group (41 vs. 18 patients of experimental group) RR=0.49 (95%CI 0.32-0.75, p<0.05) NNTB=3. Conclusions: The use of 2g amoxicillin 1 hour before surgery was not effective in significantly reducing the risk of postoperative infections from impacted mandibular third molars extraction compared to placebo. Nevertheless, antibiotic prophylaxis was associated with a reduced need for rescue analgesia.

Registry
who.int
Start Date
October 24, 2017
End Date
December 22, 2017
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Facultad de Odontología. Universidad de Chile

Eligibility Criteria

Inclusion Criteria

  • Healthy patients between 15 to 35 years old: Clinically and radiographically presence at least of one impacted mandibular third molar,

Exclusion Criteria

  • Allergy to penicillin and its derivatives.
  • Allergy to nonsteroidal anti\-inflammatory drugs.
  • Patients with gastric ulcer.
  • Patients who have undergone any type of antibiotic treatment at least 30 days before surgery.
  • Patients with pericoronaritis episode up to 7 days before the intervention.
  • Patients with psychiatric illness.
  • Immunocompromised
  • Patients with addiction to narcotic drugs or illicit substances

Outcomes

Primary Outcomes

Not specified

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