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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periodontitis, Diagnoses Disease

Intervention / Treatment
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* Device: Florida Probe Straight Tip Probe
* Device: Ball Tip Probe


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ball Tip Probe<br>One half (upper or lower jaw) of the mouth will be probed using the new trial tip (ball-end probe, 0.6mm diameter). | Device: Ball Tip Probe<br>* 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.<br>* Other names: Titanium Tip Probe;|
| Active Comparator: Florida Probe Straight Tip Probe<br>One half (upper or lower jaw) of the mouth will be probed using the current, standard probe tip (straight-end probe, 0.45mm diameter). | Device: Florida Probe Straight Tip Probe<br>* 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.<br>* Other names: Standard Tip Probe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (visual analogue scale) value 0-100mm | Patients 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. | 2 weeks |