Oral and maxillofacial surgery
A prospective placebo-controlled double-blind trial of antibiotic prophylaxis in intraoral bone grafting procedures: a pilot study

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Abstract

Objective

A pilot study was conducted to assess the efficacy of a single-dose preoperative prophylactic of the penicillin pheneticillin compared with placebo in the antibiotic prophylaxis of surgical wound infections in intra-oral bone grafting procedures.

Patients and methods

Twenty patients (age range 20-45 years) underwent an intra-oral buccal onlay graft procedure. After randomization, a placebo or 2 grams of pheneticillin were administered orally one hour before surgery in a double-blind fashion. During three months, the postoperative course was observed according to clinical parameters of infection. Both groups were homogeneous in their composition and established risk factors for surgical wound infection. The frequency of surgical wound infections, as defined by the Centers of Disease control in 1992, were compared and evaluated statistically.

Results

Two patients developed a wound infection at the receptor site; two patients developed an infection at both the receptor and donor sites; and one patient developed an infection at the donor site only. All of these patients received a placebo. No infections were seen in the pheneticillin group. There was a statistically significant increased risk of having an infectious complication after an intra-oral bone graft without antibiotic prophylaxis.

Conclusion

The results of this study support the efficacy of single-dose, preoperative, oral antibiotic administration.

Introduction

Although a great deal of investigation has been done concerning the use of prophylactic antibiotics in oral surgery, a consensus on when they are necessary has not been achieved. Postoperative surgical wound infections can have a significant effect on the outcome of surgery, which explains why patients are given preoperative or postoperative systemic antibiotics in many cases.

Oral surgery should be considered clean-contaminated operative procedures, since the intraoral surgical access inevitably entails contamination of the surgical wound with the facultative pathogenic mixed flora of the oral cavity. Also, the bacteria most frequently isolated in post-surgical infections for the most part are thought to originate from the bacteria that make up the endogenous micro-flora of the oral cavity.1

Peterson2 estimated the chance of infection in intraoral orthognathic surgical procedures without antibiotics to be 10-15%, while others3 found a higher postoperative wound infection rate (20-31%). With a short-term antibiotic prophylaxis, Lindeboom et al.4 recently found a 2.8-5.6% infection rate in mandibular sagittal ramus osteotomies.

Infections are sufficiently frequent in oral bone grafting procedures that administration of a prophylactic agent may be effective in reducing postoperative morbidity, costs, and duration of hospitalization. However, the efficacy of prophylactic antibiotic administration in buccal onlay reconstructive surgery is largely unstudied, and most oral and maxillofacial clinics use prolonged antibiotic administration for a period between 5 and 10 days in these procedures.5, 6

No controlled studies of peri-operative antibiotic prophylaxis in bone grafting procedures have demonstrated that prophylaxis will reduce postoperative infectious morbidity. There has been a paucity of data reported that details the use of prophylactic antibiotics in oral bone grafting procedures.

Pheneticillin is an oral acid-resistant penicillin analogous to penicillin V, with a range of antimicrobial activity similar to that of penicillin G.7 The property of acid resistance permits a more reliable effect from oral administration. After oral administration, peak serum levels are obtained within one-half to one hour. Higher and more prolonged serum levels are obtained compared to penicillin V administration.7

The objective of this study was to prospectively compare the outcome in preprosthetic intraoral bone grafting comparing a prophylactic oral administration of pheneticillin with a placebo.

Section snippets

Materials and methods

This pilot study was designed prospectively and performed at the Department of Oral and Maxillofacial Surgery, University of Amsterdam, Academic Medical Center Amsterdam, The Netherlands. The study comprised two groups of patients, namely the penicillin group and a placebo group.

The penicillin group was comprised of 10 patients, 6 males and 4 females, with a mean age of 26.8 years (range 18 to 45 years), and the placebo group comprised ten patients, 5 males and 5 females, with a mean age of

Results

All patients (n = 20) could be evaluated for infectious morbidity. The patient groups were comparable with respect to age and sex distribution. Two patients developed a wound infection at the receptor site, two patients developed an infection at both the receptor and donor site, one patient developed an infection at the donor site only. All of these patients received a placebo. No infections were seen in the phenethicillin group (Fig 1). Infections at the receptor site were seen at days 6-8,

Discussion

In this study, an attempt was made to clarify some of the confusion surrounding the topic of antibiotic prophylaxis in intra-oral bone grafting procedures. Studies on prophylactic administration in implant dentistry are lacking, although antibiotics are one of the largest single groups of drugs prescribed. Knowledge about their use is essential, not only because of their cost, but also because the price of their misuse may be unnecessary morbidity and mortality, high rates of hospital

References (10)

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