Skip to content

The Impact of a Modified Probe Tip Design on Patient Perception of Discomfort on Probing and Clinical Parameters Using the Florida Probe® System

The Impact of a Modified Probe Tip Design on Patient Perception of Discomfort on Probing and Clinical Parameters Using the Florida Probe® System

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03690479
Enrollment
21
Registered
2018-10-01
Start date
2013-04-04
Completion date
2017-12-14
Last updated
2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnoses Disease, Periodontitis

Brief summary

Patient perception of pain on periodontal probing using a controlled-force, electronic probe was not significantly affected by the use of a modified (ball-end) probe tip design except for in the maxilla, where a standard straight probe tip appeared to be more comfortable for patients.

Detailed description

Recordings of periodontal probing pocket depth (PPD) and probing attachment level (PAL) are utilized in diagnosis of periodontal disease and monitoring of disease progression. Manual probing presents reproducibility and accuracy issues based on features such as probe tip design, force applied by the operator and inflammatory status of the periodontal tissues. Evidence from the literature suggests that some patients may determine periodontal probing to be a painful experience. The aims of this study are to evaluate the suitability of a new titanium probe tip for periodontal probing, and to evaluate pain on periodontal probing, in comparison to the existing probe tip used in the Florida Probe® system. The study will be a randomized, blinded, split-mouth controlled trial. Twenty (20) consecutive patients meeting the inclusion criteria will be selected to undergo full-mouth periodontal probing. One half (upper or lower jaw) of the mouth will be probed using the current, standard probe tip; the opposing jaw will be probed using the new trial tip. At a second visit (within 2 weeks), prior to treatment, the mouth will be probed once again, alternating the jaws from the first visit. On each occasion, patients will report on pain on probing utilizing two ungraded 100mm horizontal visual analogue scales (VAS) representing upper and lower jaws of the mouth. Periodontal probing depth measurements will be compared to assess the reproducibility of the two probe tips. Mean VAS values and standard deviations will be calculated for the test and control groups. Data analysis will be conducted using a non-parametric statistical model (Mann-Whitney U Test). Inclusion criteria: * Adult patients: age greater than 18 years. * At least 4 tooth sites with periodontal probing pocket depth (PPD) greater or equal to 4mm. Exclusion criteria: \- Patients using ongoing daily chronic analgesic medications (NSAIDs etc) for over 3 months.

Interventions

DEVICEFlorida Probe Straight Tip Probe

Twenty (20) consecutive adult patients with a diagnosis of periodontal disease (varying degrees, from slight to severe) will be selected to undergo full-mouth periodontal probing. . One half (upper or lower jaw) of the mouth will be probed using the current, standard probe tip.

DEVICEBall Tip Probe

Twenty (20) consecutive patients meeting the inclusion criteria will be selected to undergo full-mouth periodontal probing. The opposing jaw will be probed using the new trial tip. At a second visit, prior to treatment, the mouth will be probed once again, alternating the jaws from the first visit.

Sponsors

Florida Probe Corporation
CollaboratorUNKNOWN
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age greater than 18 years. * Must have 4 tooth sites with periodontal probing pocket depth (PPD) greater or equal to 4mm.

Exclusion criteria

\- Daily use of analgesic medications (NSAIDs etc) for over 3 months.

Design outcomes

Primary

MeasureTime frameDescription
VAS (visual analogue scale) value 0-100mm2 weeksPatients will report on pain on probing utilizing two ungraded 100mm horizontal visual analogue scales (VAS): line with values from 0-100, where 0 is no pain and 100 is the worst possible pain, representing upper and lower jaws of the mouth. Periodontal probing depth measurements will be compared to assess the reproducibility of the two probe tips.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026