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

Periodontal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622192
• Other study ID #: STH 16290
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2024
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Disease
• Periodontal Diseases

Intervention

Device:
• Florida Probe automated probe
Comparisons between the reproducibility of readings taken by an automated probe and a manual probe

Locations

Country	Name	City	State
United Kingdom	University of Sheffield	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing pocket depth	Probing pocket depth with manual and electronic reading on single pass. Measurement repeated for one sextant.	pocket depth is reassessed at the same visit within 30 minutes