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

Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Dec;96(6):669-72. doi: 10.1016/j.tripleo.2003.08.026.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Alveolar Ridge Augmentation* / methods
  • Anti-Bacterial Agents / therapeutic use*
  • Antibiotic Prophylaxis*
  • Bone Transplantation* / methods
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Maxilla / surgery
  • Middle Aged
  • Penicillins*
  • Pilot Projects
  • Placebos
  • Prospective Studies
  • Risk Factors
  • Surgical Wound Infection / prevention & control

Substances

  • Anti-Bacterial Agents
  • Penicillins
  • Placebos
  • feneticillin