关键词: adjuvant therapy clinical trial local antibiotics peri-implant mucositis

来  源:   DOI:10.3390/antibiotics13030269   PDF(Pubmed)

Abstract:
OBJECTIVE: 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.
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 (p < 0.001) in both the test and the control group. Significant BoP differences (p = 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:这是随机的,安慰剂对照,双盲临床试验旨在评估专业机械去除斑块(PMPR)联合或不联合哌拉西林联合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.
方法:该研究纳入了31例种植体周围黏膜炎(探查出血(BoP)>1例患者,与以前的X光片相比,种植体周围没有骨质流失)。在随机分配到测试组和对照组后,患者接受全口龈上洁治术,有或没有哌拉西林加他唑巴坦凝胶.在基线和3个月和6个月后进行临床检查,在基线和3个月后进行微生物学检查.
结果:六个月后,两种治疗方式均导致植入部位临床参数显著减少和改善.两个研究组都没有完全解决PiM(即,每个植入物的BoP≤1)。在测试组和对照组中,在随后的时间点(p<0.001)之间,具有BoP的植入物的数量在统计学上显著减少。在治疗后6个月(与基线的差异)观察到组间的显著BoP差异(p=0.039)。
结论:在本研究的局限性内,单次使用缓慢释放,哌拉西林和他唑巴坦凝胶的局部应用抗生素组合,辅助PMPR,显示诊断为PiM的植入物的临床变量有所改善。与对照相比,辅助治疗导致更高的BoP降低,但是在其他临床和微生物学参数的变化方面没有观察到显着差异。
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