Monday, February 1, 2010
A multicentrum placebo controlled randomised clinical trial os antibiotic prophylaxis for placement of single dental implants.
A multicentrum placebo controlled randomised clinical trial os antibiotic prophylaxis for placement of single dental implants.
The use of dental implants to replace lost teeth is a widely accepted treatment. Recently, survival rates in excess of 99.2% have been published for Biotechnology Institute (BTI) dental implants inserted in different anatomical sites and using a wide range of procedures1 3. Despite the high success rates, there were occasional failures, and some of these are related to bacterial contamination at the implant insertion site4. The use of antibiotics in oral implantology, and especially of antibiotic prophylaxis, is still a matter of some debate5. Hitherto only two clinical trials have been published6,7 (Esposito et al., Abu Ta’a et al.) that have attempted to resolve this question, which is why more studies of this type are needed in order to throw additional light on the subject and allow a final conclusion to be reached. Furthermore, there are no standardized protocols for antibiotic prophylaxis in simple implant surgery, and those that are documented generally result in excessive prescription of antibiotics, both therapeutically and prophylactically6.
The aim of this study was to compare the efficacy and safety of 2 g of oral amoxicillin versus an identical amount of placebo administered as antibiotic prophylaxis one hour before the placement of single-tooth dental implants in type I and II bone. A total of 12 Spanish private clinics took part in the clinical trial. 105 patients were recruited and divided randomly into two parallel groups, receiving either amoxicillin (n=52) or a placebo (n=53). Both the onset of postoperative infections and possible adverse effects were evaluated, as well as the number of implant failures. The characteristics of the saprophytic bacteria of all the patients were also studied during the course of the study. The patients were observed 3 days, 10 days, 1 month, and 3 months after surgery.
A total of 105 patients (35 men and 70 women), with a mean age of 48 ± 12 years, were included in the study. A total of 6 postoperative infections were recorded in each treatment group. The type of treatment did not have any significant influence on the probability of suffering a postoperative infection, either independently or assuming effect-modifying variables. The infection-free time was similar in both treatment groups. A total of 4 implants failed during the course of the study period, 2 in the amoxicillin group and 2 in the placebo group; i.e. there were no significant differences between the two groups. Finally, analysis of the saprophytic bacteria did not reveal any clinical or statistical differences between the two groups (p = 0.362).
To conclude, no statistically significant differences between the two groups were found in the number of postoperative infections, infection-free time, adverse effects, number of failures, or in the characteristics of the saprophytic bacteria. No risk factors associated with the presence of postoperative infections were identified. In accordance with the results of this clinical trial, antibiotic prophylaxis is not recommended with simple single-tooth implant surgical procedures in patients with type II or III bone.
