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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Periodontal Disease
Gareth S Griffiths, BDS
01142717933
See all trial contact details
Primary Contact Details
Recruiting
Recruitment Status
NCT01622192
Primary Trial ID Number
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
Research Details
  • 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.
Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Study Type
Interventional
Intervention
Device : Florida Probe automated probe

Study Arm Groups : Automated probe

Intervention Type
See Interventions above
Primary Outcome Measures
  • Probing pocket depth; pocket depth is reassessed at the same visit within 30 minutes
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Sorry, this information is not available
Number of Participants
30
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Sheffield
S10 2SZ
Trial Contact(s)
Primary Trial Contact
Gareth S Griffiths, BDS
g.s.griffiths@sheffield.ac.uk
01142717933
Other Trial Contacts
Mahomed A Issa, BDS
MIssa1@sheffield.ac.uk
07843820039
Countries Recruiting
United Kingdom
Scientific Title
A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
STH 16290
Sponsor(s)
Sheffield Teaching Hospitals NHS Foundation Trust
Key Dates

Recruitment Start Date

Apr 2012

Recruitment End Date

Jun 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

03 May 2012

Last Updated

18 Jun 2012