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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01622192
First received: May 3, 2012
Last updated: June 18, 2012
Last verified: June 2012

May 3, 2012
June 18, 2012
April 2012
June 2012   (final data collection date for primary outcome measure)
Probing pocket depth [ Time Frame: pocket depth is reassessed at the same visit within 30 minutes ] [ Designated as safety issue: No ]
Probing pocket depth with manual and electronic reading on single pass. Measurement repeated for one sextant.
Same as current
Complete list of historical versions of study NCT01622192 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes
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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Periodontal Disease
Device: Florida Probe automated probe
Comparisons between the reproducibility of readings taken by an automated probe and a manual probe
Experimental: Automated probe
Intervention: Device: Florida Probe automated probe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
August 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Gareth S Griffiths, BDS 01142717933 g.s.griffiths@sheffield.ac.uk
Contact: Mahomed A Issa, BDS 07843820039 MIssa1@sheffield.ac.uk
United Kingdom
 
NCT01622192
STH 16290
No
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
Not Provided
Principal Investigator: Gareth S Griffiths, BDS MRD FDS University of Sheffield
Sheffield Teaching Hospitals NHS Foundation Trust
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP