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临床试验/NCT01622192
NCT01622192已完成不适用

A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Probing pocket depth

研究概览

简要总结

The aim of the study is to determine the best method for measuring the extent and severity of the gum disease by comparing the repeatability of probing depths achieved by a manual probe when compared to an automated probe.

Hypothesis

The null hypothesis to be tested includes

  • The automated probe does not improve the reproducibility of periodontal probing when compared to manual probing recordings

  • The automated probe shows no advantage when comparing the reproducibility of

  • Moderate sites

  • Deep sites

  • Single vs. multirooted teeth

  • Different sextants

  • Different surfaces of teeth Buccal vs. palatal/lingual Mesial vs. mid vs. distal

详细描述

Measuring the clinical attachment loss using a periodontal probe is the benchmark by which attachment loss is diagnosed in periodontal disease. The accuracy and reproducibility of the probing measurements is an essential part of diagnosis, treatment planning and assessment of the treatment outcome. There are inherent errors associated with probing that have been identified in the literature. These relate to the operator technique, the probe used and the state of inflammation of the periodontal pocket/crevice.

The aim of this study is to compare the reproducibility of probing measurements using a probe tip with millimeter markings up to 15mm in the Florida probe ® handpiece. This tip will be used to allow conventional clinical measurements to be recorded at the same time as the electronic recordings on the Florida probe ®. The examiner would take the manual probe measurement and be blind to the electronic reading taken. The sites under question will have a second measurement recorded to allow assessment of the repeatability of the recordings. Therefore, from 2 probing passes 4 measurements would be obtained 2 manual and 2 electronic readings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Age 18 and over
  • Diagnosis of periodontitis (any form) but must have at least 2 sites in at least 1 sextant with a BPE code 4( pockets ≥ 5.5mm) at the time of screening
  • Patient consent gained and has agreed to be a part of the study

排除标准

  • Any medical condition that would exclude them from having the measurements taken
  • Any medical problem that would make participation difficult
  • If they do not have sufficient sites where probing depths are required.

结局指标

主要结局

Probing pocket depth

时间窗: pocket depth is reassessed at the same visit within 30 minutes

Probing pocket depth with manual and electronic reading on single pass. Measurement repeated for one sextant.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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