Effect of antibiotic prophylaxis in dental implant surgery: A multicenter placebo-controlled double-blinded randomized clinical trial

Palwasha Momand, Jonas P Becktor, Aron Naimi-Akbar, Gunnar Tobin, Bengt Götrick, Palwasha Momand, Jonas P Becktor, Aron Naimi-Akbar, Gunnar Tobin, Bengt Götrick

Abstract

Background: The growing resistance of bacteria to antimicrobial medicines is a global issue and a direct threat to human health. Despite this, antibiotic prophylaxis is often still routinely used in dental implant surgery to prevent bacterial infection and early implant failure, despite unclear benefits. There is a lack of sufficient evidence to formulate clear clinical guidelines and therefore there is a need for well-designed, large-scale randomized controlled trials to determine the effect of antibiotic prophylaxis.

Purpose: To compare the effect of a presurgical antibiotic regimen with an identical placebo regimen in healthy or relatively healthy patients receiving dental implants.

Materials and methods: The 474 patients participating in the study were recruited from seven clinics in southern Sweden. We randomized the patients into a test and a placebo group; the study was conducted double-blinded. Preoperatively, the test group received 2 g of amoxicillin and the control group, identical placebo tablets. The primary outcome was implant failure; secondary outcomes were postoperative infections and adverse events. Patients were evaluated at two follow-ups: at 7-14 days and at 3-6 months.

Results: Postoperative evaluations of the antibiotic (n = 238) and the placebo (n = 235) groups noted implant failures (antibiotic group: six patients, 2.5% and placebo group: seven patients, 3.0%) and postoperative infections (antibiotic group: two patients, 0.8% and placebo group: five patients, 2.1%). No patient reported any adverse events. Between-group differences in implant failures and postoperative infections were nonsignificant.

Conclusion: Antibiotic prophylaxis in conjunction with implant placement is likely of small benefit and should thus be avoided in most cases, especially given the unabated growth in antibiotic-resistant bacteria.

Clinical trial registration number: NCT03412305.

Keywords: antibiotic prophylaxis; dental implants; multicenter placebo-controlled randomized clinical trial.

Conflict of interest statement

The authors declare no conflict of interest.

© 2022 The Authors. Clinical Implant Dentistry and Related Research Published by Wiley Periodicals LLC.

Figures

FIGURE 1
FIGURE 1
Flowchart diagram of the study protocol according to Consort guideline

References

    1. World Health Organization . Global Action Plan on Antimicrobial Resistance. World Health Organization; 2015.
    1. Bell BG, Schellevis F, Stobberingh E, Goossens H, Pringle M. A systematic review and meta‐analysis of the effects of antibiotic consumption on antibiotic resistance. BMC Infect Dis. 2014;14:13.
    1. Prestinaci F, Pezzotti P, Pantosti A. Antimicrobial resistance: a global multifaceted phenomenon. Pathog Glob Health. 2015;109(7):309‐318.
    1. Moraschini V, Poubel LA, Ferreira VF, Barboza ES. Evaluation of survival and success rates of dental implants reported in longitudinal studies with a follow‐up period of at least 10 years: a systematic review. Int J Oral Maxillofac Surg. 2015;44(3):377‐388.
    1. Brånemark P‐I, Zarb GA, Albrektsson T. Tissue‐Integrated Prostheses : Osseointegration in Clinical Dentistry. Quintessence Publ. Co. Inc; 1985.
    1. Esposito M, Grusovin MG, Maghaireh H, Worthington HV. Interventions for replacing missing teeth: different times for loading dental implants. Cochrane Database Syst Rev. 2013;2013(3):Cd003878.
    1. Esposito M, Cannizzaro G, Bozzoli P, et al. Efficacy of prophylactic antibiotics for dental implants: a multicentre placebo‐controlled randomised clinical trial. Eur J Oral Implantol. 2008;1(1):23‐31.
    1. Esposito M, Cannizzaro G, Bozzoli P, et al. Effectiveness of prophylactic antibiotics at placement of dental implants: a pragmatic multicentre placebo‐controlled randomised clinical trial. Eur J Oral Implantol. 2010;3(2):135‐143.
    1. Anitua E, Aguirre JJ, Gorosabel A, et al. A multicentre placebo‐controlled randomised clinical trial of antibiotic prophylaxis for placement of single dental implants. Eur J Oral Implantol. 2009;2(4):283‐292.
    1. Caiazzo A, Casavecchia P, Barone A, Brugnami F. A pilot study to determine the effectiveness of different amoxicillin regimens in implant surgery. J Oral Implantol. 2011;37(6):691‐696.
    1. Nolan R, Kemmoona M, Polyzois I, Claffey N. The influence of prophylactic antibiotic administration on post‐operative morbidity in dental implant surgery. A prospective double blind randomized controlled clinical trial. Clin Oral Implants Res. 2014;25(2):252‐259.
    1. Abu‐Ta'a M, Quirynen M, Teughels W, van Steenberghe D. Asepsis during periodontal surgery involving oral implants and the usefulness of peri‐operative antibiotics: a prospective, randomized, controlled clinical trial. J Clin Periodontol. 2008;35(1):58‐63.
    1. Lund B, Hultin M, Tranaeus S, Naimi‐Akbar A, Klinge B. Complex systematic review ‐ perioperative antibiotics in conjunction with dental implant placement. Clin Oral Implants Res. 2015;26(Suppl 11):1‐14.
    1. Arduino PG, Tirone F, Schiorlin E, Esposito M. Single preoperative dose of prophylactic amoxicillin versus a 2‐day postoperative course in dental implant surgery: a two‐centre randomised controlled trial. Eur J Oral Implantol. 2015;8(2):143‐149.
    1. Klinge B, Flemming T, Cosyn J, et al. The patient undergoing implant therapy. Summary and consensus statements. The 4th EAO consensus conference 2015. Clin Oral Implants Res. 2015;26(Suppl 11):64‐67.
    1. Rodríguez Sánchez F, Rodríguez Andrés C, Arteagoitia I. Which antibiotic regimen prevents implant failure or infection after dental implant surgery? A systematic review and meta‐analysis. J Craniomaxillofac Surg. 2018;46(4):722‐736.
    1. Braun RS, Chambrone L, Khouly I. Prophylactic antibiotic regimens in dental implant failure: a systematic review and meta‐analysis. J Am Dent Assoc. 2019;150(6):e61‐e91.
    1. Romandini M, De Tullio I, Congedi F, et al. Antibiotic prophylaxis at dental implant placement: which is the best protocol? A systematic review and network meta‐analysis. J Clin Periodontol. 2019;46(3):382‐395.
    1. Jain A, Rai A, Singh A, Taneja S. Efficacy of preoperative antibiotics in prevention of dental implant failure: a meta‐analysis of randomized controlled trials. Oral Maxillofac Surg. 2020;24(4):469‐475.
    1. Canullo L, Troiano G, Sbricoli L, et al. The use of antibiotics in implant therapy: a systematic review and meta‐analysis with trial sequential analysis on early implant failure. Int J Oral Maxillofac Implants. 2020;35(3):485‐494.
    1. Roca‐Millan E, Estrugo‐Devesa A, Merlos A, Jané‐Salas E, Vinuesa T, López‐López J. Systemic antibiotic prophylaxis to reduce early implant failure: a systematic review and meta‐analysis. Antibiotics (Basel). 2021;10(6).698.
    1. Caiazzo A, Canullo L, Pesce P. Consensus report by the Italian Academy of Osseointegration on the use of antibiotics and antiseptic agents in implant surgery. Int J Oral Maxillofac Implants. 2021;36(1):103‐105.
    1. Doyle DJ, Goyal A, Bansal P, Garmon EH. American society of anesthesiologists classification. StatPearls. StatPearls Publishing LLC; 2021.
    1. Isla A, Canut A, Rodríguez‐Gascón A, et al. Pharmacokinetic/pharmacodynamic analysis of antibiotic therapy in dentistry and stomatology. Enferm Infecc Microbiol Clin. 2005;23(3):116‐121.
    1. Chunduri NS, Madasu K, Goteki VR, Karpe T, Reddy H. Evaluation of bacterial spectrum of orofacial infections and their antibiotic susceptibility. Ann Maxillofac Surg. 2012;2(1):46‐50.
    1. Habib G, Lancellotti P, Antunes MJ, et al. 2015 ESC guidelines for the management of infective endocarditis. Kardiol Pol. 2015;73(11):963‐1027.
    1. Dajani AS, Taubert KA, Wilson W, et al. Prevention of bacterial endocarditis recommendations by the American Heart Association. JAMA. 1997;277(22):1794‐1801.
    1. Jinno Y, Jimbo R, Hjalmarsson J, Johansson K, Stavropoulos A, Becktor JP. Impact of surface contamination of implants with saliva during placement in augmented bone defects in sheep calvaria. Br J Oral Maxillofac Surg. 2019;57(1):41‐46.
    1. Chrcanovic BR, Kisch J, Albrektsson T, Wennerberg A. Factors influencing early dental implant failures. J Dent Res. 2016;95(9):995‐1002.
    1. Tan WC, Ong M, Han J, et al. Effect of systemic antibiotics on clinical and patient‐reported outcomes of implant therapy ‐ a multicenter randomized controlled clinical trial. Clin Oral Implants Res. 2014;25(2):185‐193.
    1. Payer M, Tan WC, Han J, et al. The effect of systemic antibiotics on clinical and patient‐reported outcome measures of oral implant therapy with simultaneous guided bone regeneration. Clin Oral Implants Res. 2020;31(5):442‐451.
    1. Kashani H, Hilon J, Rasoul MH, Friberg B. Influence of a single preoperative dose of antibiotics on the early implant failure rate. A randomized clinical trial. Clin Implant Dent Relat Res. 2019;21(2):278‐283.
    1. WHO . Global Action Pan on Antimicrobial Resistance. World Health Organization; 2015.
    1. Khalil D, Hultin M, Rashid MU, Lund B. Oral microflora and selection of resistance after a single dose of amoxicillin. Clin Microbiol Infect. 2016;22(11):949.e941‐949.e944.
    1. Ventola CL. The antibiotic resistance crisis: part 1: causes and threats. P t. 2015;40(4):277‐283.
    1. Spellberg B, Gilbert DN. The future of antibiotics and resistance: a tribute to a career of leadership by John Bartlett. Clin Infect Dis. 2014;59(Suppl 2):S71‐S75.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel