Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-02-03 @ 4:41 AM
Study NCT ID:
NCT01622192
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2012-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Study Overview
Official Title:
A Comparison Between the Repeatability of Probing Pocket Depths Achieved With Manual and Automated Periodontal Probes
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: