跳至主要内容
临床试验/NCT02023840
NCT02023840已完成4 期

The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Periodontitis: a Split-mouth Randomized Controlled Clinical Trial

Proed, Torino, Italy1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Probing pocket Depth change

研究概览

简要总结

Aim of the present study is evaluate the use of erythritol powder with/without the adjunct of local metronidazole in the treatment of periodontal pockets.

20 consecutive adult periodontal patients, requiring cause-related therapy as phase 1 of their treatment plan, and presenting ≥4 sites with probing pocket depth ≥4mm will be enrolled. For each patients four sites will be considered for the study, and two sites will be allocated in the test group and two sites will be allocated in the control group. In the test group, ultrasonic debridement of the pocket will be performed using a piezoceramic ultrasonic device with the a tip connected to the handpiece for 5 minutes/pocket. Then, it will be followed by the subgingival use of erythritol powder 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. In the control group, the same protocol will be used except for the use of a placebo instead of metronidazole. After instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.

At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated: Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).

详细描述

The long term results and benefit of infection control in the treatment of periodontal disease have been well documented. According to a cause-related concept, the disruption of bacterial plaque biofilms can be defined as primary objective for the treatment of periodontitis.

In the past few years, glycine powder air polishing showed positive outcomes in removing subgingival biofilm in periodontal pockets, and subgingivally delivered metronidazole seemed to improve the results of scaling and root-planing alone . Recently, a new prophylactic powder has been developed. The special action of the powder is attributable to the new ingredient Erythritol and the extra-fine grains that measure only 14 microns. The small size results on one hand in a minimal impact per grain on the treated surface and on the other hand in a very dense jet of powder, efficient on biofilm.

Aim of the present study is evaluate the use of erythritol powder with/without the adjunct of local metronidazole in the treatment of periodontal pockets.

MATERIALS & METHODS:

20 consecutive adult periodontal patients, requiring cause-related therapy as phase 1 of their treatment plan, and presenting ≥4 sites with probing pocket depth ≥4mm will be enrolled. For each patients four sites will be considered for the study, and two sites will be allocated in the test group and two sites will be allocated in the control group. In the test group, ultrasonic debridement of the pocket will be performed using a piezoceramic ultrasonic device with the tip connected to the Handpiece Led for 5 minutes/pocket. Then, it will be followed by the subgingival use of erythritol powder applied by the use of Perio-Flow Handpiece with Perio-Flow Nozzle, connected to an airflow unit 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. In the control group, the same protocol will be used except for the use of a placebo instead of metronidazole. After instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients suffering from periodontitis at least 4 sites with probing pocket depth =>4mm

排除标准

  • Heavy smokers current pregnant patients history of malignancy Long term steroidal or antibiotic therapy

研究组 & 干预措施

ultrasonics and erythritol, metronidazole gel

Active Comparator

Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of metronidazole gel

干预措施: metronidazole gel (Drug)

ultrasonics and erythritol, metronidazole gel

Active Comparator

Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of metronidazole gel

干预措施: ultrasonics (Procedure)

ultrasonics and erythritol, metronidazole gel

Active Comparator

Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of metronidazole gel

干预措施: erythritol (Procedure)

ultrasonics and erythritol, placebo

Placebo Comparator

Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of placebo

干预措施: ultrasonics (Procedure)

ultrasonics and erythritol, placebo

Placebo Comparator

Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of placebo

干预措施: erythritol (Procedure)

ultrasonics and erythritol, placebo

Placebo Comparator

Scaling and root planing with ultrasonics and erythritol air powder will be followed by application of placebo

干预措施: placebo (Drug)

结局指标

主要结局

Probing pocket Depth change

时间窗: baseline, 6 months

Using a periodontal calibrated PCP-15 mm probe, the pocket depth will be measured

Bleeding on Probing change

时间窗: baseline, 6 months

Using a periodontal calibrated PCP-15 mm probe, the bleeding on probing will be detected

Clinical Attachment level change

时间窗: baseline, 6 months

Using a periodontal calibrated PCP-15 mm probe, the attachment level will be measured

次要结局

未报告次要终点

研究者

发起方
Proed, Torino, Italy
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验