Effect of antibiotic prophylaxis in dental implant surgery: A multicenter placebo-controlled double-blinded randomized clinical trial.
Effect of antibiotic prophylaxis in dental implant surgery: A multicenter placebo-controlled double-blinded randomized clinical trial.
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抗生素预防在牙种植手术中的效果：一项多中心安慰剂对照双盲随机临床试验。
DOI：
10.1111/cid.13068
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发表时间：
2022-03
影响因子：
3.6
通讯作者：
中科院分区：
文献类型：
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作者：
细菌对抗菌药物的耐药性日益增加是一个全球性问题，直接威胁着人类健康。尽管如此，抗生素预防通常仍然常规用于牙科种植手术，以防止细菌感染和早期种植失败，尽管益处尚不清楚。目前缺乏足够的证据来制定明确的临床指南，因此需要设计良好的大规模随机对照试验来确定抗生素预防的效果。比较术前抗生素治疗方案与相同安慰剂治疗方案在接受牙种植体的健康或相对健康患者中的效果。参与这项研究的474名患者来自瑞典南部的7家诊所。我们将患者随机分为试验组和安慰剂组;该研究是双盲进行的。术前，试验组接受2 g阿莫西林，对照组接受相同的安慰剂片剂。主要结局为植入物失效;次要结局为术后感染和不良事件。在两次随访时对患者进行评价：7-14天和3-6个月。抗生素组（n = 238）和安慰剂组（n = 235）的术后评价记录了植入失败（抗生素组：6例患者，2.5%，安慰剂组：7例患者，3.0%）和术后感染（抗生素组：2例患者，0.8%，安慰剂组：5例患者，2.1%）。无患者报告任何不良事件。植入物失效和术后感染的组间差异不显著。抗生素预防联合种植体植入可能获益不大，因此在大多数情况下应避免，特别是考虑到抗生素耐药菌的增长有增无减。临床试验注册号：NCT 03412305。
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. To compare the effect of a presurgical antibiotic regimen with an identical placebo regimen in healthy or relatively healthy patients receiving dental implants. 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. 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. 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.
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DOI：
10.3390/antibiotics10060698
发表时间：
2021-06-10
期刊：
Antibiotics (Basel, Switzerland)
影响因子：
--
作者：
Roca-Millan E;Estrugo-Devesa A;Merlos A;Jané-Salas E;Vinuesa T;López-López J
通讯作者：
López-López J
影响因子：
14.2
作者：
Khalil, D.;Hultin, M.;Lund, B.
通讯作者：
Lund, B.
影响因子：
3.9
作者：
Braun, Rosalie S.;Chambrone, Leandro;Khouly, Ismael
通讯作者：
Khouly, Ismael
影响因子：
4.3
作者：
Payer, Michael;Tan, Wah Ching;Lang, Niklaus P.
通讯作者：
Lang, Niklaus P.
影响因子：
3.6
作者：
Kashani, Hossein;Hilon, Jack;Friberg, Bertil
通讯作者：
Friberg, Bertil