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Inconclusive evidence to recommend prophylactic antibiotics to prevent complications following dental implant treatment
R EVIEWS
OF
S YSTEMATIC R EVIEWS
Inconclusive evidence to recommend prophylactic antibiotics to prevent complications following dental implant treatment Susan G. Reed Medical University of South Carolina
Original Article
Level of Evidence Purpose
Source of Funding
Type of Study/Design
Esposito M, Coulthard P, Oliver R, Thomsen P, Worthington HV. Antibiotics to prevent complications following dental implant treatment (Cochrane Review). In: The Cochrane Library, Issue 3, 2003. Oxford: Update Software. Date of most recent amendment: 17 April 2003
3a This review tested the null hypothesis of no difference in the proportion of prosthetic failures, implant failures, postoperative infections, and adverse events of patients receiving a placebo or no antibiotic treatment. Swedish Medical Research Council (9495) SWEDEN Sahlgrenska Academy at Goteborg University SWEDEN The University Dental Hospital of Manchester UK Systematic review
Summary SUBJECTS No randomized controlled clinical trials were found. Two published controlled clinical trials were identified. The prospective trial compared survival rates for 2973 implants. The retrospective controlled clinical trials compared 147 participants with a control group of 132. These 2 groups were treated in different time periods, the 147 participants between 1980 and 1985, and the control group between 1991 and 1995.
J Evid Base Dent Pract 2004;4:210-1 D 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.jebdp.2004.07.021
210
EXPOSURE In the prospective trial, the exposures of various prophylactic antibiotic regimens (dosages and regimens determined by individual investigators) versus no antibiotics were tested. In the retrospective study, the exposure was 1 g of phenoxymethylpenicillin administered 1 hour preoperatively and every 8 hours for 10 days. MAIN OUTCOME MEASURE The outcome measures included implant survival where failure was defined as removal of an implant that did not osseointegrate. A failed implant was identified by buccal-lingual mobility. In the retrospective study the outcome measure of postoperative
infection was defined as presence of purulent drainage or fistula together with pain, swelling, redness, and heat or fever.
MAIN RESULTS In the first prospective trial, the conclusion was that implants in patients who received preoperative antibiotics had significantly higher survival rates compared to implants in patients who had not received preoperative antibiotics. In the controlled clinical trials, no statistically significant differences with respect to postoperative infections or implant survival were observed. CONCLUSION The reviewers conclude that the scientific evidence is not sufficient to either recommend or discourage the use of preoperative systemic antibiotics to prevent dental implant complications and failures.
Commentary and Analysis This review outlined suitable criteria for consideration of studies and the search strategy for identification of studies. The objectives of the review were to assess the beneficial or harmful effects of the administration of prophylactic antibiotics for dental implant placement versus no antibiotic/placebo administration and, if antibiotics are of benefit, to find which type, dosage, and duration is the most effective. Though this review found that there is not enough evidence to answer the objectives, the topic of this review is important to clinicians for several reasons: ! Dental implants are widely used to replace missing teeth, and despite high success rates, failures do occur.1 ! Belief is that some of these failures are caused by bacterial contamination at implant insertion, and infection around biomaterials are very difficult to treat, and almost all infected implants have to be removed sooner or later.2 ! In general, antibiotic prophylaxis in surgery is only indicated in the following situations: patient is at risk of infectious endocarditis, patients has reduced host-response, surgery is performed in infected sites, extensive and prolonged surgical interventions are required, and large foreign materials are implanted. ! Adverse events (from diarrhea to life-threatening allergic reactions) may occur with antibiotic usage.
Journal of Evidence-Based Dental Practice Volume 4, Number 3
! A major concern associated with the widespread use of antibiotics is the selection of antibioticresistant bacteria. This topic demonstrates the prescriptive and prospective purposes of the results of the systemic review efforts of the Cochrane Collaboration. In prescription, the evidence is not sufficient to recommend or discourage use of preoperative systemic antibiotics for dental implant placement. Prospectively, reasonable expectations for the future are well-designed studies to provide evidence to encourage or discourage the use of systemic antibiotics, before or after dental implant surgery, to prevent complications and failures of dental implants.
WEAKNESSES AND STRENGTHS The major weaknesses of the 2 studies of the review were the biased methodologies. MAJOR ISSUES WITH IMPLANT OUTCOMES RESEARCH AND THE IMPACT ON EVIDENCE FOR CLINICAL PRACTICES The major issue identified by this review was lack of adequate studies and the insufficiencies of the studies and therefore the need for randomized controlled clinical trials on this topic. The suggestion from the reviewers is to begin with a large, double-blind, placebo controlled randomized clinical trial assessing whether or not the use of a single dose of 2 g of amoxicillin 1 hour before implant placement decreases postoperative complications and implant failures. The impact on evidence for clinical practices at this time is not determined. The scientific evidence is not sufficient to either recommend or discourage the use of preoperative systemic antibiotics in clinical practice to prevent dental implant complications and failures. The intent of this review was not to assess the use of prophylactic antibiotics for patients at risk for endocarditis. However, the reviewers are in accord with use of prophylactic antibiotics for those patients with the following conditions: higher risk for endocarditis, immunodeficiencies, metabolic diseases, irradiated areas of the head and neck, and anticipated extensive and prolonged dental implant or abutment surgeries. REFERENCES 1. Esposito M, Hirsch JM, Kekholm U, Thomsen P. Biological factors contributing to failures of osseointegrated oral implants. (I) Success criteria and epidemiology. Eur J Oral Sci 1998;106:527-51. 2. Esposito M, Hirsch JM, Kekholm U, Thomsen P. Biological factors contributing to failures of osseointegrated oral implants. (II) Etiopathogenesis. Eur J Oral Sci 1998;106:721-64.
Reed
211
OF
S YSTEMATIC R EVIEWS
Inconclusive evidence to recommend prophylactic antibiotics to prevent complications following dental implant treatment Susan G. Reed Medical University of South Carolina
Original Article
Level of Evidence Purpose
Source of Funding
Type of Study/Design
Esposito M, Coulthard P, Oliver R, Thomsen P, Worthington HV. Antibiotics to prevent complications following dental implant treatment (Cochrane Review). In: The Cochrane Library, Issue 3, 2003. Oxford: Update Software. Date of most recent amendment: 17 April 2003
3a This review tested the null hypothesis of no difference in the proportion of prosthetic failures, implant failures, postoperative infections, and adverse events of patients receiving a placebo or no antibiotic treatment. Swedish Medical Research Council (9495) SWEDEN Sahlgrenska Academy at Goteborg University SWEDEN The University Dental Hospital of Manchester UK Systematic review
Summary SUBJECTS No randomized controlled clinical trials were found. Two published controlled clinical trials were identified. The prospective trial compared survival rates for 2973 implants. The retrospective controlled clinical trials compared 147 participants with a control group of 132. These 2 groups were treated in different time periods, the 147 participants between 1980 and 1985, and the control group between 1991 and 1995.
J Evid Base Dent Pract 2004;4:210-1 D 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.jebdp.2004.07.021
210
EXPOSURE In the prospective trial, the exposures of various prophylactic antibiotic regimens (dosages and regimens determined by individual investigators) versus no antibiotics were tested. In the retrospective study, the exposure was 1 g of phenoxymethylpenicillin administered 1 hour preoperatively and every 8 hours for 10 days. MAIN OUTCOME MEASURE The outcome measures included implant survival where failure was defined as removal of an implant that did not osseointegrate. A failed implant was identified by buccal-lingual mobility. In the retrospective study the outcome measure of postoperative
infection was defined as presence of purulent drainage or fistula together with pain, swelling, redness, and heat or fever.
MAIN RESULTS In the first prospective trial, the conclusion was that implants in patients who received preoperative antibiotics had significantly higher survival rates compared to implants in patients who had not received preoperative antibiotics. In the controlled clinical trials, no statistically significant differences with respect to postoperative infections or implant survival were observed. CONCLUSION The reviewers conclude that the scientific evidence is not sufficient to either recommend or discourage the use of preoperative systemic antibiotics to prevent dental implant complications and failures.
Commentary and Analysis This review outlined suitable criteria for consideration of studies and the search strategy for identification of studies. The objectives of the review were to assess the beneficial or harmful effects of the administration of prophylactic antibiotics for dental implant placement versus no antibiotic/placebo administration and, if antibiotics are of benefit, to find which type, dosage, and duration is the most effective. Though this review found that there is not enough evidence to answer the objectives, the topic of this review is important to clinicians for several reasons: ! Dental implants are widely used to replace missing teeth, and despite high success rates, failures do occur.1 ! Belief is that some of these failures are caused by bacterial contamination at implant insertion, and infection around biomaterials are very difficult to treat, and almost all infected implants have to be removed sooner or later.2 ! In general, antibiotic prophylaxis in surgery is only indicated in the following situations: patient is at risk of infectious endocarditis, patients has reduced host-response, surgery is performed in infected sites, extensive and prolonged surgical interventions are required, and large foreign materials are implanted. ! Adverse events (from diarrhea to life-threatening allergic reactions) may occur with antibiotic usage.
Journal of Evidence-Based Dental Practice Volume 4, Number 3
! A major concern associated with the widespread use of antibiotics is the selection of antibioticresistant bacteria. This topic demonstrates the prescriptive and prospective purposes of the results of the systemic review efforts of the Cochrane Collaboration. In prescription, the evidence is not sufficient to recommend or discourage use of preoperative systemic antibiotics for dental implant placement. Prospectively, reasonable expectations for the future are well-designed studies to provide evidence to encourage or discourage the use of systemic antibiotics, before or after dental implant surgery, to prevent complications and failures of dental implants.
WEAKNESSES AND STRENGTHS The major weaknesses of the 2 studies of the review were the biased methodologies. MAJOR ISSUES WITH IMPLANT OUTCOMES RESEARCH AND THE IMPACT ON EVIDENCE FOR CLINICAL PRACTICES The major issue identified by this review was lack of adequate studies and the insufficiencies of the studies and therefore the need for randomized controlled clinical trials on this topic. The suggestion from the reviewers is to begin with a large, double-blind, placebo controlled randomized clinical trial assessing whether or not the use of a single dose of 2 g of amoxicillin 1 hour before implant placement decreases postoperative complications and implant failures. The impact on evidence for clinical practices at this time is not determined. The scientific evidence is not sufficient to either recommend or discourage the use of preoperative systemic antibiotics in clinical practice to prevent dental implant complications and failures. The intent of this review was not to assess the use of prophylactic antibiotics for patients at risk for endocarditis. However, the reviewers are in accord with use of prophylactic antibiotics for those patients with the following conditions: higher risk for endocarditis, immunodeficiencies, metabolic diseases, irradiated areas of the head and neck, and anticipated extensive and prolonged dental implant or abutment surgeries. REFERENCES 1. Esposito M, Hirsch JM, Kekholm U, Thomsen P. Biological factors contributing to failures of osseointegrated oral implants. (I) Success criteria and epidemiology. Eur J Oral Sci 1998;106:527-51. 2. Esposito M, Hirsch JM, Kekholm U, Thomsen P. Biological factors contributing to failures of osseointegrated oral implants. (II) Etiopathogenesis. Eur J Oral Sci 1998;106:721-64.
Reed
211