The Impact of a Modified Probe Tip Design on Patient Perception of Discomfort on Probing and Clinical Parameters Using the Florida Probe® System
NCT ID: NCT03690479
Last Updated: 2018-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2013-04-04
2017-12-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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Ball Tip Probe
One half (upper or lower jaw) of the mouth will be probed using the new trial tip (ball-end probe, 0.6mm diameter).
Ball 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.
Florida Probe Straight Tip Probe
One half (upper or lower jaw) of the mouth will be probed using the current, standard probe tip (straight-end probe, 0.45mm diameter).
Florida 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.
Interventions
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Florida 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.
Ball 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have 4 tooth sites with periodontal probing pocket depth (PPD) greater or equal to 4mm.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Florida Probe Corporation
UNKNOWN
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Peter Harrison, DMD
Role: PRINCIPAL_INVESTIGATOR
School of Dental Science - Trinity College Dublin
Locations
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University of Florida College of Dentistry
Gainesville, Florida, United States
Countries
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References
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Canakci V, Canakci CF. Pain levels in patients during periodontal probing and mechanical non-surgical therapy. Clin Oral Investig. 2007 Dec;11(4):377-83. doi: 10.1007/s00784-007-0126-z. Epub 2007 Jun 19.
Fowler C, Garrett S, Crigger M, Egelberg J. Histologic probe position in treated and untreated human periodontal tissues. J Clin Periodontol. 1982 Sep;9(5):373-85. doi: 10.1111/j.1600-051x.1982.tb02048.x.
Hassan MA, Bogle G, Quishenbery M, Stephens D, Riggs M, Egelberg J. Pain experienced by patients during periodontal recall examination using thinner versus thicker probes. J Periodontol. 2005 Jun;76(6):980-4. doi: 10.1902/jop.2005.76.6.980.
Heft MW, Perelmuter SH, Cooper BY, Magnusson I, Clark WB. Relationship between gingival inflammation and painfulness of periodontal probing. J Clin Periodontol. 1991 Mar;18(3):213-5. doi: 10.1111/j.1600-051x.1991.tb01137.x.
Magnusson I, Fuller WW, Heins PJ, Rau CF, Gibbs CH, Marks RG, Clark WB. Correlation between electronic and visual readings of pocket depths with a newly developed constant force probe. J Clin Periodontol. 1988 Mar;15(3):180-4. doi: 10.1111/j.1600-051x.1988.tb01566.x.
Robinson PJ, Vitek RM. The relationship between gingival inflammation and resistance to probe penetration. J Periodontal Res. 1979 May;14(3):239-43. doi: 10.1111/j.1600-0765.1979.tb00229.x. No abstract available.
Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.
Al-Ajmix M, Bogle G, Cole R, Rathbun E, Riggs M, Egelberg J. Ability of examiners to estimate the pain experienced by patients from probing during initial periodontal examination. J Periodontol. 2005 Jun;76(6):985-90. doi: 10.1902/jop.2005.76.6.985.
Chung DT, Bogle G, Bernardini M, Stephens D, Riggs ML, Egelberg JH. Pain experienced by patients during periodontal maintenance. J Periodontol. 2003 Sep;74(9):1293-301. doi: 10.1902/jop.2003.74.9.1293.
Other Identifiers
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244-2011
Identifier Type: -
Identifier Source: org_study_id
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