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
  Purpose

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

Condition Intervention Phase
Periodontal Disease
Device: Florida Probe automated probe
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes

Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Automated probe Device: Florida Probe automated probe
Comparisons between the reproducibility of readings taken by an automated probe and a manual probe

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622192

Contacts
Contact: Gareth S Griffiths, BDS 01142717933 g.s.griffiths@sheffield.ac.uk
Contact: Mahomed A Issa, BDS 07843820039 MIssa1@sheffield.ac.uk

Locations
United Kingdom
University of Sheffield Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2SZ
Contact: Gareth S Griffiths    01142717933    g.s.griffiths@sheffield.ac.uk   
Contact: Mahomed A Issa, BDS    07843820039    MIssa1@shefffield.ac.uk   
Principal Investigator: Gareth S Griffiths         
Sub-Investigator: Mahomed A Issa         
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Gareth S Griffiths, BDS MRD FDS University of Sheffield
  More Information

No publications provided

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01622192     History of Changes
Other Study ID Numbers: STH 16290
Study First Received: May 3, 2012
Last Updated: June 18, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Probing
manual probe
automated probe
Periodontal disease

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 14, 2014