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Diode Laser and Green Indocyanine in the Non-surgical Treatment of Periodontitis

2020年12月15日 更新者:Luigi Guida、University of Campania "Luigi Vanvitelli"

The Use of Diode Laser and Green Indocyanine Solution in Adjunct to Full-mouth Ultrasonic Debridement in the Treatment of Periodontitis: a Randomized Controlled Trial

This is a parallel-group, randomized controlled clinical trial aimed to evaluate the clinical and microbiological effects of the adjunctive topical use of diode laser and green indocyanine in the full-mouth ultrasonic debridement of patients affected by periodontitis.

研究概览

地位

完全的

条件

详细说明

Periodontitis is a chronic inflammatory disease affecting the supporting tissues of the teeth and is primarily caused by the subgingival inflammation induced by the bacterial oral biofilm. Several risk factors may condition its development and progression and, if untreated, periodontitis may lead to tooth loss and severe functional and aesthetic impairments.

A central role in the non-surgical treatment of periodontitis is played by the manual and ultrasonic debridement of supra and subgingival bacterial deposits. The benefit of a fully ultrasonic approach lies in the knowledge that removing radicular structure is not a prerequisite for periodontal healing.

However, non-surgical therapy has limitations due to limited access to some sites (furcation areas, concavities, grooves, distal sites of molars, and deep pockets), which may impair periodontal healing due to the persistence of pathogens and subsequent recolonization. In this context, the use of diode laser in combination with photoactivated solutions has been proposed as an adjunct treatment to conventional periodontal therapy to enhance the antibacterial effect and improve clinical effects, especially in areas of difficult access.

In view of theme relevance and the existence of conflicting results in the literature, the aim of the present parallel-group, randomized controlled clinical trial is to evaluate the clinical and microbiological effects of the adjunctive topical use of diode laser and indocyanine green (DLIG) in the full-mouth ultrasonic debridement (FMUD) of patients affected by periodontitis.

24 patients will be treated by FMUD and, after 7 days, randomly allocated half to the test and a half to the control group. In the test group, patients will receive an adjunctive treatment in periodontal sites with an initial pocket depth > 4mm consisting of the use of a diode laser device (Fox ARC, Sweden & Martina, Due Carrare, Italy) after pocket irrigation by a solution of indocyanine green (Emundo®, Sweden&Martina, Due Carrare, Padova, Italy), whereas the patients in the control group will receive sham treatment (ST). The same treatment will be repeated three weeks after in both the test and control groups.

Clinical assessment and microbiological analysis of subgingival plaque will be performed at baseline and after 3 and 6 months.

研究类型

介入性

注册 (实际的)

24

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion criteria:

  • Diagnosis of moderate to severe periodontitis
  • Systemic health

Exclusion criteria:

  • Systemic diseases requiring antibiotic prophylaxis or other systemic medication that could affect the patient's clinical response
  • Periodontal treatment within the last 12 months or systemic antibiotic intake in the last 3 months
  • Pregnancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Test (FMUD + DLIG)
Periodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by irrigation with indocyanine green solution and diode laser irradiation.
Full-Mouth Ultrasonic Debridement + Diode Laser and Indocyanine Green solution
其他名称:
  • Diode laser: Fox ARC, Sweden & Martina, Due Carrare, Italy
  • indocyanine green photosensitizer solution: Emundo®, Sweden&Martina, Due Carrare, Padova, Italy
假比较器:Control (FMUD + ST)
Periodontal pockets are treated by ultrasonic debridement and, after 7 and 28 days, by sham therapy.
Full-Mouth Ultrasonic Debridement + Sham Treatment

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Probing depth (PD) reduction
大体时间:6 months
The distance between the bottom of the pocket and the gingival margin recorded with a manual probe using a light force and measured to the closest millimeter
6 months

次要结果测量

结果测量
措施说明
大体时间
Recession (REC) increase
大体时间:6 months
The distance between the gingival margin and the cemento-enamel junction or the margin of the restoration.
6 months
Clinical Attachment Level (CAL) gain
大体时间:Baseline, 3 and 6 months
Calculated as PD plus REC.
Baseline, 3 and 6 months
Microbiological analysis
大体时间:6 months
Semi-quantitative analysis by PCR
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Luigi Guida, Prof.、University of Campania "Luigi Vanvitelli"

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年10月12日

初级完成 (实际的)

2018年9月3日

研究完成 (实际的)

2018年9月3日

研究注册日期

首次提交

2020年12月7日

首先提交符合 QC 标准的

2020年12月15日

首次发布 (实际的)

2020年12月17日

研究记录更新

最后更新发布 (实际的)

2020年12月17日

上次提交的符合 QC 标准的更新

2020年12月15日

最后验证

2020年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • Laser/01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

FMUD + DLIG的临床试验

3
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