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使用和不使用赤藓糖醇喷砂治疗种植体周围炎的非手术治疗:一项 12 个月的随机对照试验。

Non-surgical treatment of peri-implantitis with and without erythritol air-polishing a 12-month randomized controlled trial.

机构信息

Department of Clinical Dentistry, Faculty of Medicine, University of Bergen, Aarstadveien 19, N-5009, Bergen, Norway.

Oris Dental Madla, Stavanger, Norway.

出版信息

BMC Oral Health. 2023 Apr 24;23(1):240. doi: 10.1186/s12903-023-02973-5.

Abstract

BACKGROUND

A variety of interventions have been explored in the non-surgical management of peri-implantitis. In spite of extensive testing of various study protocols, effective treatments largely remain unavailable. The objective of the present 12-month single-centre, examiner-masked, randomized controlled clinical trial was to explore whether a low-abrasive erythritol air-polishing system produces added clinical benefit when used adjunctive to conventional non-surgical management of peri-implantitis and to record any associated patient-centered outcomes.

METHODS

Forty-three patients with mild to severe peri-implantitis including at least one implant either received ultrasonic/curette subgingival instrumentation and erythritol air-polishing (test) or ultrasonic/curette instrumentation only (control) at baseline and at 3, 6, 9, and 12 months. Probing depth (PD), bleeding on probing (BoP), dental plaque, suppuration (SUP), crestal bone level (CBL), and peri-implant crevicular fluid (PCF) were recorded at baseline, 6 and 12 months. Visual Analogue Scale (VAS) scores were collected immediately following subgingival interventions at all time-points.

RESULTS

A reduction in PD was observed from baseline to 6 months for the test (p = 0.006) and control (p < 0.001) and from baseline to 12 months for the control (p < 0.001). No intergroup differences were observed for primary outcome variables PD or CBL over time (p > 0.05). At 6 months, a intergroup difference in PCF was observed in favor of the test (p = 0.042). Moreover, a reduction in SUP from baseline to 6 and 12 months was observed in the test (p = 0.019). Overall, patients in the control group experienced less pain/discomfort compared with the test (p < 0.05), females reporting more pain/discomfort than males (p = 0.005).

CONCLUSIONS

This study confirms that conventional non-surgical management of peri-implantitis produces limited clinical improvement. It is shown that an erythritol air-polishing system may not produce added clinical benefits when used adjunctive to conventional non-surgical management. In other words, neither approach effectively resolved peri-implantitis. Moreover, the erythritol air-polishing system produced added pain/discomfort particularly in female patients.

TRIAL REGISTRATION

The clinical trial was prospectively registered in ClinicalTrials.gov with registration NCT04152668 (05/11/2019).

摘要

背景

在种植体周围炎的非手术治疗中,已经探索了多种干预措施。尽管对各种研究方案进行了广泛的测试,但仍然缺乏有效的治疗方法。本 12 个月、单中心、检查者盲法、随机对照临床试验的目的是探讨当与种植体周围炎的常规非手术治疗联合使用时,低磨损的赤藓糖醇喷砂系统是否能带来额外的临床获益,并记录任何相关的以患者为中心的结果。

方法

43 名患有轻至重度种植体周围炎的患者,至少有一个种植体在基线时和第 3、6、9 和 12 个月时接受了超声/龈下刮治器械和赤藓糖醇喷砂(试验)或超声/龈下刮治器械(对照)治疗。在基线、第 6 和第 12 个月记录探诊深度(PD)、探诊出血(BoP)、牙菌斑、溢脓(SUP)、牙槽嵴骨水平(CBL)和种植体周围龈沟液(PCF)。在所有时间点,在龈下干预后立即采集视觉模拟量表(VAS)评分。

结果

试验组 PD 从基线到 6 个月(p=0.006)和对照组 PD 从基线到 6 个月(p<0.001)以及对照组 PD 从基线到 12 个月(p<0.001)均有下降。主要结局变量 PD 或 CBL 随时间的变化在两组间无差异(p>0.05)。在 6 个月时,试验组 PCF 有统计学差异(p=0.042)。此外,试验组 SUP 从基线到 6 个月和 12 个月均有下降(p=0.019)。总体而言,与试验组相比,对照组患者的疼痛/不适程度较低(p<0.05),女性比男性报告的疼痛/不适更多(p=0.005)。

结论

本研究证实,种植体周围炎的常规非手术治疗仅能带来有限的临床改善。结果表明,当与常规非手术治疗联合使用时,赤藓糖醇喷砂系统可能不会带来额外的临床获益。换句话说,这两种方法都不能有效地解决种植体周围炎。此外,赤藓糖醇喷砂系统会带来额外的疼痛/不适,尤其是在女性患者中。

试验注册

该临床试验前瞻性地在 ClinicalTrials.gov 注册,注册号为 NCT04152668(2019 年 11 月 5 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e7ac/10127096/1b722e72098c/12903_2023_2973_Fig1_HTML.jpg

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