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

NCT ID: NCT01622192

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-05-31

Brief 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

Detailed 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.

Conditions

Periodontal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Automated probe

Group Type: EXPERIMENTAL

Florida Probe automated probe

Intervention Type: DEVICE

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

Interventions

Florida Probe automated probe

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gareth S Griffiths, BDS MRD FDS

Role: PRINCIPAL_INVESTIGATOR

University of Sheffield

Locations

University of Sheffield

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

STH 16290

Identifier Type: -

Identifier Source: org_study_id