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Completed

NCT Number: NCT03690479

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

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.

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Key information

Conditions

Periodontitis Diagnoses Disease Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Florida Probe Straight Tip Probe

Device

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.

Other names: Standard Tip Probe

Ball Tip Probe

Device

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.

Other names: Titanium Tip Probe

Primary outcomes

  1. VAS (visual analogue scale) value 0-100mm

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Florida Probe Corporation

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Oct 1, 2018
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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