NCT01622192

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

May 3, 2012

Last Update Submit

January 2, 2024

Conditions

Periodontal Disease

Keywords

Probingmanual probeautomated probePeriodontal disease

Outcome Measures

Primary Outcomes (1)

  • Probing pocket depth

    Probing pocket depth with manual and electronic reading on single pass. Measurement repeated for one sextant.

    pocket depth is reassessed at the same visit within 30 minutes

Study Arms (1)

Automated probe

EXPERIMENTAL
Device: Florida Probe automated probe

Interventions

Florida Probe automated probeDEVICE

Comparisons between the reproducibility of readings taken by an automated probe and a manual probe

Automated probe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sheffield

Sheffield, South Yorkshire, S10 2SZ, United Kingdom

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Gareth S Griffiths, BDS MRD FDS

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2012

First Posted

June 19, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

GB(1)