A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes
Primary Purpose
Periodontal Disease
Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Florida Probe automated probe
Sponsored by
About this trial
This is an interventional diagnostic trial for Periodontal Disease focused on measuring Probing, manual probe, automated probe, Periodontal disease
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.
Sites / Locations
- University of SheffieldRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Automated probe
Arm Description
Outcomes
Primary Outcome Measures
Probing pocket depth
Probing pocket depth with manual and electronic reading on single pass. Measurement repeated for one sextant.
Secondary Outcome Measures
Full Information
NCT ID
NCT01622192
First Posted
May 3, 2012
Last Updated
June 18, 2012
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01622192
Brief Title
A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes
Official Title
A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
Keywords
Probing, manual probe, automated probe, Periodontal disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Automated probe
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Florida Probe automated probe
Intervention Description
Comparisons between the reproducibility of readings taken by an automated probe and a manual probe
Primary Outcome Measure Information:
Title
Probing pocket depth
Description
Probing pocket depth with manual and electronic reading on single pass. Measurement repeated for one sextant.
Time Frame
pocket depth is reassessed at the same visit within 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gareth S Griffiths, BDS
Phone
01142717933
Email
g.s.griffiths@sheffield.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Mahomed A Issa, BDS
Phone
07843820039
Email
MIssa1@sheffield.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gareth S Griffiths, BDS MRD FDS
Organizational Affiliation
University of Sheffield
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sheffield
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2SZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gareth S Griffiths
Phone
01142717933
Email
g.s.griffiths@sheffield.ac.uk
First Name & Middle Initial & Last Name & Degree
Mahomed A Issa, BDS
Phone
07843820039
Email
MIssa1@shefffield.ac.uk
First Name & Middle Initial & Last Name & Degree
Gareth S Griffiths
First Name & Middle Initial & Last Name & Degree
Mahomed A Issa
12. IPD Sharing Statement
Learn more about this trial
A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes
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