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临床试验/NCT07005219
NCT07005219已完成不适用

Efficacy of Minimal vs. Conventional Apical Preparation With Passive Ultrasonic Irrigation in Reducing Intracanal Bacteria: A Clinical Study

Medipol University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年2月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Reduction in Bacterial Load

研究概览

简要总结

This study evaluates intracanal bacterial load in molar teeth with chronic apical periodontitis before and after root canal shaping with two different apical enlargement sizes and ultrasonic irrigation activation.

详细描述

This randomized controlled clinical trial investigated the effect of different apical enlargement sizes and passive ultrasonic irrigation (PUI) on the bacterial load in the mesial roots of mandibular molars diagnosed with chronic apical periodontitis. The study was conducted at Istanbul Medipol University Faculty of Dentistry, Endodontics Clinic, and included 24 patients who required primary root canal treatment and exhibited clinical and radiographic signs of chronic apical periodontitis.

Participants were randomly assigned to two groups (n=12 each). In Group 1, root canal shaping was performed using a One Curve Mini #25/0.4 rotary file. In Group 2, shaping was performed using a One Curve Mini #35/0.4 rotary file. In both groups, passive ultrasonic irrigation was applied using the VDW Ultra device with an IRRI S 21/25 ultrasonic tip. The irrigation protocol consisted of three 20-second cycles using 1 ml of 3% sodium hypochlorite (NaOCl) per cycle. The ultrasonic tip was positioned 2 mm short of the working length without contacting the canal walls.

Bacterial samples were collected from the mesial root canals during the treatment. The bacterial load was quantified using Droplet Digital PCR (ddPCR), a highly sensitive and precise molecular technique that allows absolute quantification of bacterial DNA. This method was chosen because it enables accurate detection of bacterial reduction following the interventions.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •a non-contributory medical history
  • •must have an asymptomatic mandibular molar with periapical lesions of>2.0x2.0 mm around the mesial roots
  • •must be diagnosed as chronic apical periodontitis

排除标准

  • •Patients with acute clinical symptoms
  • •Teeth with previous root canal treatment
  • •non-restorable teeth

研究组 & 干预措施

Apical Enlargement with One Curve Mini #25/0.4 (Minimal Invasive Shaping)

Experimental

Intervention:

  • Root canal shaping using One Curve Mini #25/0.4 rotary file.
  • Irrigation with 3% NaOCl.
  • Passive Ultrasonic Irrigation (PUI) using IRRI S 21/25 tip on VDW Ultra device.
  • 3 cycles of ultrasonic activation (each 20 seconds, 1 ml NaOCl per cycle).
  • Ultrasonic tip placed 2 mm short of working length, without contacting canal walls.

干预措施: Root canal shaping with One Curve Mini #25/0.4 and passive ultrasonic irrigation (Procedure)

Apical Enlargement with One Curve Mini #35/0.4 (Conventional Shaping)

Experimental

Intervention:

  • Root canal shaping using One Curve Mini #35/0.4 rotary file.
  • Irrigation with 3% NaOCl.
  • Passive Ultrasonic Irrigation (PUI) using IRRI S 21/25 tip on VDW Ultra device.
  • 3 cycles of ultrasonic activation (each 20 seconds, 1 ml NaOCl per cycle).
  • Ultrasonic tip placed 2 mm short of working length, without contacting canal walls.

干预措施: Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigation (Procedure)

结局指标

主要结局

Reduction in Bacterial Load

时间窗: During operation.

Quantitative reduction in bacterial load in the mesial root canals of mandibular molars with apical periodontitis, as measured by Droplet Digital PCR (ddPCR), following different apical enlargement sizes and passive ultrasonic irrigation activation, provides quantitative data that can be statistically analyzed to compare the two intervention groups (#25/0.4 vs. #35/0.4 apical enlargement).

次要结局

未报告次要终点

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melike Yavuz

Director, Clinical Research

Medipol University

研究点 (1)

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