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单剂量哌拉西林加他唑巴坦凝胶作为种植体周围黏膜炎患者专业机械性菌斑清除(PMPR)辅助治疗的6个月双盲随机临床试验。

A Single Dose of Piperacillin Plus Tazobactam Gel as an Adjunct to Professional Mechanical Plaque Removal (PMPR) in Patients with Peri-Implant Mucositis: A 6-Month Double-Blind Randomized Clinical Trial.

作者信息

Ilyes Ioana, Boariu Marius, Rusu Darian, Iorio-Siciliano Vincenzo, Vela Octavia, Boia Simina, Kardaras Georgios, Șurlin Petra, Calniceanu Horia, Jentsch Holger, Lodin Alexandru, Stratul Stefan-Ioan

机构信息

Department of Periodontology, Faculty of Dental Medicine, Anton Sculean Research Center for Periodontal and Peri-Implant Diseases, "Victor Babes" University of Medicine and Pharmacy, 300041 Timisoara, Romania.

Department of Endodontics, Faculty of Dental Medicine, TADERP Research Center, "Victor Babes" University of Medicine and Pharmacy, 300041 Timisoara, Romania.

出版信息

Antibiotics (Basel). 2024 Mar 17;13(3):269. doi: 10.3390/antibiotics13030269.

Abstract

OBJECTIVES

This randomized, placebo-controlled, double-masked clinical trial aimed to evaluate the clinical and microbiological efficacy of professional mechanical plaque removal (PMPR) with or without adjunctive application of piperacillin plus tazobactam gel in the treatment of peri-implant mucositis (PiM) for up to 6 months.

MATERIALS AND METHODS

The study included 31 patients with peri-implant mucositis (bleeding on probing (BoP) > 1 at at least one site at baseline, absence of peri-implant bone loss compared with a previous radiograph). After randomized assignment to test and control groups, patients received full-mouth supragingival scaling with or without piperacillin plus tazobactam gel. Clinical examination was performed at baseline and after 3 and 6 months, and a microbiological examination was performed at baseline and after 3 months.

RESULTS

After six months, both treatment modalities resulted in significant reductions and improvements in clinical parameters at the implant sites. Neither study group achieved a complete resolution of PiM (i.e., BoP ≤ 1 per implant). The number of implants with BoP decreased statistically significantly between subsequent time points ( < 0.001) in both the test and the control group. Significant BoP differences ( = 0.039) were observed between groups at 6 months (difference to baseline) following therapy.

CONCLUSIONS

Within the limitations of the present study, the single use of a slow-release, locally applied antibiotic combination of piperacillin and tazobactam gel, adjunctive to PMPR, showed an improvement in clinical variable of implants diagnosed with PiM. The adjunctive treatment resulted in higher BoP reduction when compared to the control, but no significant differences were observed regarding the changes in other clinical and microbiological parameters.

摘要

目的

本随机、安慰剂对照、双盲临床试验旨在评估专业机械菌斑清除(PMPR)联合或不联合应用哌拉西林加他唑巴坦凝胶治疗种植体周围黏膜炎(PiM)长达6个月的临床和微生物学疗效。

材料与方法

该研究纳入31例种植体周围黏膜炎患者(基线时至少一个部位探诊出血(BoP)>1,与之前的X线片相比无种植体周围骨丢失)。随机分为试验组和对照组后,患者接受全口龈上洁治,试验组联合哌拉西林加他唑巴坦凝胶,对照组不联合。在基线、3个月和6个月时进行临床检查,在基线和3个月时进行微生物学检查。

结果

6个月后,两种治疗方式均使种植体部位的临床参数显著降低和改善。两个研究组均未实现PiM的完全缓解(即每个种植体BoP≤1)。试验组和对照组中,后续时间点之间BoP阳性的种植体数量均有统计学显著下降(<0.001)。治疗后6个月(与基线相比的差异),两组之间观察到显著的BoP差异(=0.039)。

结论

在本研究的局限性内,单独使用缓释、局部应用的哌拉西林和他唑巴坦凝胶抗生素组合辅助PMPR,显示出诊断为PiM的种植体临床变量有所改善。与对照组相比,辅助治疗导致BoP降低更多,但在其他临床和微生物学参数的变化方面未观察到显著差异。

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