drugset / Trial / NCT03130933

Complications After Lower Third Molar Surgery

NCT03130933

Phase 1/2 Completed 400 enrolled University of Zagreb
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Objectives: The objective of the study was to evaluate the effectiveness of a prophylactic single preoperative dose of amoxicillin in decreasing complications after lower third molar surgery. Materials and methods: The sample consisted of 400 patients randomly divided in two groups consisting of 200 patients per each group. The patients underwent third molar surgery at the Department of Oral Surgery, Clinical Hospital Dubrava, Croatia, in the period between April 2010. and November 2016. Unlike the patients from the second group, the first group of patients had never been diagnosed inflammation prior the surgical procedure. The main tested groups were further divided in two subgroups (control and tested): the tested subgroup (100 patients) received a prophylactic single dose of 2 g amoxicillin an hour prior the procedure, while the second control subgroup (100 patients) received a placebo. Complications, including swelling, alveolar osteitis (AO), infection at the surgical site (SSI), limited mouth opening, pain, bleeding, and increased body temperature, were evaluated postoperatively. Evaluation was done on the first postoperative day and 7 days after surgery.

Timeline

Start
2010-04
Primary completion
2016-11
Completion
2016-11

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 2 g