Majid Omer Waleed
Professor, Department of Oral and Maxillofacial Surgery, College of Dentistry, Mosul University, Mosul, Iraq.
Evid Based Dent. 2024 Dec;25(4):174-175. doi: 10.1038/s41432-024-01011-9. Epub 2024 May 8.
A randomized, double-blind, placebo-controlled clinical trial.
To assess the impact of antibiotic prophylaxis on postoperative recovery and implant short-term survival in clinically healthy patients who underwent placement of 2-4 dental implants by inexperienced operators.
The study adhered to the ethical guidelines of the Helsinki declaration, and followed the CONSORT protocol for randomized controlled trials (RCTs). Signed consent forms were provided by all patients. Included were healthy individuals aged over 18 years, with sufficient and fully healed alveolar ridge (undergone extraction at least 3 months prior), requiring placement of 2-4 dental implants, and were classified as ASA I or II. Exclusion criteria were: systemic diseases, hypersensitivity to penicillin, pregnancy or lactation, smoking, recent antibiotic usage, and history of periodontitis. Patients were randomly allocated into 2 groups: the antibiotic group received 1 g of amoxicillin one hour before surgery, while the placebo group was given starch-filled capsules that looked identical to the antibiotic. All implants were installed through 2-stage procedures by students of a specialization course in implant surgery, employing a standardized procedure and armamentarium. Each patient was evaluated preoperatively, and at 2 days and 7 days postoperatively, for the following parameters: mouth opening, experienced pain (using a visual analog scale), and signs of infection (fistula, wound ulceration, tissue necrosis, flap dehiscence, and purulent exudates). Implant survival was monitored for up to 90 days after implant surgery.
A total of 90 patients (224 implants) were included: 43 patients (108 implants) in the antibiotic group, and 47 patients (116 implants) in the placebo group. Overall, there were 58 women and 32 men, aged from 23 to 70 years old. In terms of mouth opening, pain, and infection parameters, no statistically significant differences were observed between the groups at any of the time points evaluated. Similarly, there was no statistically significant difference regarding antibiotic usage and implant loss at the patient level (p = 0.06). However, at the implant level, significantly higher implant loss rate was noted in the placebo group (14.9%) compared to the antibiotic group (2.3%) [p < 0.05].
Prophylactic antibiotic administration effectively reduced the occurrence of implant loss after implant surgery performed by inexperienced practitioners.
一项随机、双盲、安慰剂对照临床试验。
评估抗生素预防对临床健康患者术后恢复及种植体短期存留率的影响,这些患者由经验不足的医生植入2至4颗牙种植体。
本研究遵循赫尔辛基宣言的伦理准则,并遵循随机对照试验(RCT)的CONSORT方案。所有患者均签署了知情同意书。纳入的患者为年龄超过18岁的健康个体,牙槽嵴充分且完全愈合(至少在3个月前已拔牙),需要植入2至4颗牙种植体,且美国麻醉医师协会(ASA)分级为I或II级。排除标准为:全身性疾病、对青霉素过敏、妊娠或哺乳期、吸烟、近期使用过抗生素以及有牙周炎病史。患者被随机分为两组:抗生素组在手术前1小时服用1克阿莫西林,而安慰剂组服用外观与抗生素相同的淀粉填充胶囊。所有种植体均由种植外科专业课程的学生通过两阶段手术植入,采用标准化程序和器械。对每位患者在术前、术后2天和7天进行评估,评估以下参数:开口度、疼痛程度(使用视觉模拟量表)以及感染迹象(瘘管、伤口溃疡、组织坏死、皮瓣裂开和脓性渗出物)。种植体植入术后监测其存留情况长达90天。
共纳入90例患者(224颗种植体):抗生素组43例患者(108颗种植体),安慰剂组47例患者(116颗种植体)。总体而言,有58名女性和32名男性,年龄在23至70岁之间。在开口度、疼痛和感染参数方面,在评估的任何时间点两组之间均未观察到统计学上的显著差异。同样,在患者层面,抗生素使用和种植体丢失方面也没有统计学上的显著差异(p = 0.06)。然而,在种植体层面,与抗生素组(2.3%)相比,安慰剂组的种植体丢失率显著更高(14.9%)[p < 0.05]。
预防性使用抗生素有效降低了经验不足的医生进行种植体植入手术后种植体丢失的发生率。