Infection Clinical Trial
Official title:
Antibiotic Efficacy in Third Molar Surgery
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.
The management of impacted M3s is a high volume procedure. In the United States, the cost of
M3 removal has been estimated to be over 2 billion dollars, not including costs for
consults, x-rays, medications, surgical center charges, or over 5 million surgical
extractions and treatment of postoperative inflammatory complications (Flick. 1999).
Practices associated with M3 removal can have a significant impact on large numbers of
patients, providers, and payers. There is currently no consensus on the use of systemic
antibiotic prophylaxis to decrease the risk of inflammatory complications following M3
removal.The most common post-operative inflammatory complications following M3 extraction
are alveolar osteitis (AO) and wound infection (Larsen, 1992; Piecuch et al., 1995; Sekar et
al., 2001). AO, aka "dry socket," is a wound-healing problem characterized by severe,
unremitting pain. The reported frequency of AO is 6-68%. Bacterial colonization stimulates
plasmin production and fibrinolysis with dissolution of the extraction site clot . More than
45% of patients who sustain AO require 4 or 5 more postoperative appointments for resolution
of symptoms (Larsen, 1992; Andra et al., 1990). Given its common occurrence, identifying
treatments, i.e. systemic antibiotics, to decrease the rate of AO following M3 extraction
would be an important contribution to enhancing patient outcomes. The second common
postoperative inflammatory condition following M3 extraction is wound infection. The
reported frequency of postoperative infection ranges from 1.2 - 27%, with most studies
reporting a frequency of <10%. Because wound infections are bacterial, it is hypothesized
that using systemic antibiotics will reduce the rate of postoperative wound infections.
There are, however, no definitive prospective studies that support or refute the necessity
of systemic antibiotics in the prevention of postoperative inflammatory complications of AO
or infection.
All studies published to date addressing the role of systemic antibiotics and M3 removal
have one or more major methodological flaws in study design characterized as :1) no or
ambiguous definition of the outcome variable, 2) inadequate sample size, 3) non-uniformity
of protocol design, 4) lack of randomization techniques and 5) poor-follow-up monitoring.
Clearly, there is a need for a definitive, rigorous, well-designed placebo-controlled
randomized clinical trial to ascertain the efficacy of systemic antibiotics in preventing
postoperative inflammatory complications after M3 removal.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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