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OpenTrials
Completed

NCT Number: NCT01622192

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sheffield

Sheffield, South Yorkshire, S10 2SZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Florida Probe automated probe

Device

Comparisons between the reproducibility of readings taken by an automated probe and a manual probe

Primary outcomes

  1. Probing pocket depth

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 19, 2012
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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