A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes
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|ClinicalTrials.gov Identifier: NCT01622192|
Recruitment Status : Unknown
Verified June 2012 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : June 19, 2012
Last Update Posted : June 19, 2012
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.
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 or disease||Intervention/treatment||Phase|
|Periodontal Disease||Device: Florida Probe automated probe||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||August 2012|
|Experimental: Automated probe||
Device: Florida Probe automated probe
Comparisons between the reproducibility of readings taken by an automated probe and a manual probe
- Probing pocket depth [ Time Frame: pocket depth is reassessed at the same visit within 30 minutes ]Probing pocket depth with manual and electronic reading on single pass. Measurement repeated for one sextant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622192
|Contact: Gareth S Griffiths, BDSfirstname.lastname@example.org|
|Contact: Mahomed A Issa, BDS||07843820039||MIssa1@sheffield.ac.uk|
|University of Sheffield||Recruiting|
|Sheffield, South Yorkshire, United Kingdom, S10 2SZ|
|Contact: Gareth S Griffiths 01142717933 email@example.com|
|Contact: Mahomed A Issa, BDS 07843820039 MIssa1@shefffield.ac.uk|
|Principal Investigator: Gareth S Griffiths|
|Sub-Investigator: Mahomed A Issa|
|Principal Investigator:||Gareth S Griffiths, BDS MRD FDS||University of Sheffield|