The Effect of Preoperative Antibiotics on Peri-implant Healing

Summary

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 ≤ 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.

Timeline

Start

2020-02-25

Primary completion

2023-12-01

Completion

2023-12-01

Publications

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• Background Ireland RS, Palmer NO, Lindenmeyer A, Mills N. An investigation of antibiotic prophylaxis in implant practice in the UK. Br Dent J. 2012 Oct;213(8):E14. doi: 10.1038/sj.bdj.2012.960.
• Background Deeb GR, Soung GY, Best AM, Laskin DM. Antibiotic Prescribing Habits of Oral and Maxillofacial Surgeons in Conjunction With Routine Dental Implant Placement. J Oral Maxillofac Surg. 2015 Oct;73(10):1926-31. doi: 10.1016/j.joms.2015.05.024. Epub 2015 Jun 6.
• Background Braun RS, Chambrone L, Khouly I. Prophylactic antibiotic regimens in dental implant failure: A systematic review and meta-analysis. J Am Dent Assoc. 2019 Jun;150(6):e61-e91. doi: 10.1016/j.adaj.2018.10.015. Epub 2019 Apr 20.
• Background Esposito M, Grusovin MG, Worthington HV. Interventions for replacing missing teeth: antibiotics at dental implant placement to prevent complications. Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD004152. doi: 10.1002/14651858.CD004152.pub4.
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• Background Noedl H, Krudsood S, Chalermratana K, Silachamroon U, Leowattana W, Tangpukdee N, Looareesuwan S, Miller RS, Fukuda M, Jongsakul K, Sriwichai S, Rowan J, Bhattacharyya H, Ohrt C, Knirsch C. Azithromycin combination therapy with artesunate or quinine for the treatment of uncomplicated Plasmodium falciparum malaria in adults: a randomized, phase 2 clinical trial in Thailand. Clin Infect Dis. 2006 Nov 15;43(10):1264-71. doi: 10.1086/508175. Epub 2006 Oct 12.
• Background Gomi K, Yashima A, Iino F, Kanazashi M, Nagano T, Shibukawa N, Ohshima T, Maeda N, Arai T. Drug concentration in inflamed periodontal tissues after systemically administered azithromycin. J Periodontol. 2007 May;78(5):918-23. doi: 10.1902/jop.2007.060246.
• Background Haffajee AD, Torresyap G, Socransky SS. Clinical changes following four different periodontal therapies for the treatment of chronic periodontitis: 1-year results. J Clin Periodontol. 2007 Mar;34(3):243-53. doi: 10.1111/j.1600-051X.2006.01040.x.
• Background Giamarellos-Bourboulis EJ. Macrolides beyond the conventional antimicrobials: a class of potent immunomodulators. Int J Antimicrob Agents. 2008 Jan;31(1):12-20. doi: 10.1016/j.ijantimicag.2007.08.001. Epub 2007 Nov 1.
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Drugs

Indications

No indication recorded.