Antibiotic Efficacy in Third Molar Surgery

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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Inclusion criteria

• Demographics: While all ages are eligible for study enrollment, as a practical matter, most patients having M3s removed are usually > 13-14 years of age.
• Gender: Males and females will be offered to participate in this study.
• Race: All races and ethnicities are eligible for study enrollment.
• Clinical status: at least one impacted mandibular third molar ( M3 ) must be scheduled for extraction.
• Anesthesia: Patient request that the procedure be executed using intravenous sedation or general anesthesia. Intravenous sedation will be accomplished with use of an IV placed in the antecubital fossa of each patient
• Health status: Healthy patients or patients with mild systemic disease, i.e. ASA status < 3, are eligible for study enrollment.

Exclusion criteria

• Pre-existing infection: Infection is characterised as having an area with frank purulence and/or cellulitis characterized by erythema, induration and inability to open the mouth wide enough to provide access to the airway.
• Pre-existing Systemic Illness: as evidenced by severe dry mouth, patients who have undergone radiotherapy for oral cancer, patients that are immunocompromised, patients that require antibiotic prophylaxis for endocarditis, as well as, patients who are taking antimicrobials for other systemic diseases, i.e., uncontrolled diabetes., ASA status > 2.
• Allergic Reactions to Medications: Patients who are allergic to Penicillin and Clindamycin will be excluded from the study.
• Anesthesia: Patient request that the operation be performed with local anesthesia without intravenous sedation or general anesthesia.
• Pregnancy: Pregnancy is a relative contraindication for study enrollment. If after consultation with the obstetrician, there is no contraindication to removing the impacted teeth with sedation or contraindication to receiving the test medications (penicillin or clindamycin) and the patient wants to pursue treatment, she would be considered eligible for study enrollment.