Despite over 50 years of antibiotic use and multiple clinical investigations (>50), no
definitive studies exist to confirm or refute the use of systemic antibiotics to prevent
postoperative inflammatory complications after third molar (M3), aka "wisdom teeth" removal.
Among patients having M3s extracted, does the administration of systemic prophylactic
antibiotics when compared to placebo, decrease the rate of postoperative inflammatory
complications? The first specific aim of the study is to implement a randomized,
placebo-controlled clinical trial to determine if systemic prophylactic antibiotics, when
compared to placebo, decrease the rate of postoperative alveolar osteitis (AO) after M3
extraction. For this proposal, postoperative AO is the primary outcome variable.
The second specific aim is to implement a pilot study using a randomized, placebo-controlled
clinical trial to determine if systemic prophylactic antibiotics, when compared to placebo,
decrease the rate of postoperative infection after M3 extraction. For the purposes of this
proposal, postoperative infection is a secondary outcome variable. Based on sample size
estimates, we believe it will be necessary to implement a multi-year trial to address the
second specific aim definitively. As such, we will use the experience and preliminary results
derived from this clinical trial to develop and implement a future large scale clinical
trial.
The third specific aim is to identify risk factors associated with postoperative inflammatory
complications in order to develop a model to predict if the prophylactic administration of
antibiotics will prevent the postoperative inflammatory complications of alveolar osteitis
and infection following the removal of M3's.
The long-term goal of this project is to provide compelling clinical evidence to support
recommendations regarding the use of systemic antibiotics in this setting and alter clinical
practice based on the results of a well-done, definitive clinical investigation.
Phase:
Phase 3
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborator:
Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois