Preoperative Antibiotics on Peri-Implant Healing
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“The Effect of Preoperative Antibiotics on Peri-implant Healing”
Introduction: In order to minimize postoperative morbidity and failures of dental implant therapy, several antibiotic regimens have been proposed in the literature. However, the extensive use of antibiotics in health care has been debated due to the adverse effects and bacterial resistance. Furthermore, the impact of preoperative antibiotics on peri-implant bone level is still not clear. Objectives: The primary objective of this study will be to assess whether giving preoperative antibiotics (azithromycin 500mg) after implant placement over 7 days will influence peri-implant crestal bone levels after 4 months in healthy patients undergoing platform-switched implant placement. The secondary objectives will be to evaluate postoperative pain severity, surgery-associated morbidities, and 1-year implant survival rate. Methods: Fifty individuals will be recruited in a double-masked 2-arm randomized clinical trial. Participants in the intervention group will receive 500mg of azithromycin 1 hour before implant placement. Participants in the control group will take one placebo 1 hour preoperatively. The changes in mesial and distal crestal bone level (primary outcome) will be measured at baseline and 4-month follow-up using standardized periapical radiographs. Pain severity and surgery-associated morbidities (secondary outcomes) will be evaluated by clinical examinations and self-administered questionnaires. Implant survival rate will be assessed at the 1-year follow-up. Descriptive and bivariate analyses will be used to analyze the data. A P value a?$ 0.05 will be considered statistically significant. Clinical relevance: This study will be the first placebo-controlled double-blinded randomized clinical trial studying the effect of preoperative azithromycin on radiographical, clinical and patient-based outcomes after implant surgery. This type of design will reduce as much as possible the risk of bias and increasing the quality of evidence. The results from this study might help provide guidelines for clinicians that will optimize implant survival rate while decreasing antibiotics exposure to patients undergoing straightforward implant surgery.
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Drug - Azithromycin
azithromycin 500mg one hour before implant placement
Drug - Placebo oral tablet
identical placebo one hour before implant placement
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The Effect of Preoperative Antibiotics on Peri-implant Crestal Bone Remodelling and Postoperative Pain: A Randomized Controlled Trial
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NCT04280406
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bW6Z4a