The Impact of a Modified Probe Tip Design on Patient Perception of Discomfort on Probing and Clinical Parameters Using the Florida Probe® System
Primary Purpose
Periodontitis, Diagnoses Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Florida Probe Straight Tip Probe
Ball Tip Probe
Sponsored by
About this trial
This is an interventional diagnostic trial for Periodontitis
Eligibility Criteria
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.
Sites / Locations
- University of Florida College of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ball Tip Probe
Florida Probe Straight Tip Probe
Arm Description
One half (upper or lower jaw) of the mouth will be probed using the new trial tip (ball-end probe, 0.6mm diameter).
One half (upper or lower jaw) of the mouth will be probed using the current, standard probe tip (straight-end probe, 0.45mm diameter).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03690479
First Posted
September 25, 2018
Last Updated
September 28, 2018
Sponsor
University of Florida
Collaborators
Florida Probe Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03690479
Brief Title
The Impact of a Modified Probe Tip Design on Patient Perception of Discomfort on Probing and Clinical Parameters Using the Florida Probe® System
Official Title
The Impact of a Modified Probe Tip Design on Patient Perception of Discomfort on Probing and Clinical Parameters Using the Florida Probe® System
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 4, 2013 (Actual)
Primary Completion Date
September 6, 2014 (Actual)
Study Completion Date
December 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Florida Probe Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Diagnoses Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ball Tip Probe
Arm Type
Active Comparator
Arm Description
One half (upper or lower jaw) of the mouth will be probed using the new trial tip (ball-end probe, 0.6mm diameter).
Arm Title
Florida Probe Straight Tip Probe
Arm Type
Active Comparator
Arm Description
One half (upper or lower jaw) of the mouth will be probed using the current, standard probe tip (straight-end probe, 0.45mm diameter).
Intervention Type
Device
Intervention Name(s)
Florida Probe Straight Tip Probe
Other Intervention Name(s)
Standard Tip Probe
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Ball Tip Probe
Other Intervention Name(s)
Titanium Tip Probe
Intervention Description
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.
Primary Outcome Measure Information:
Title
VAS (visual analogue scale) value 0-100mm
Description
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.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Harrison, DMD
Organizational Affiliation
School of Dental Science - Trinity College Dublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida College of Dentistry
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17576606
Citation
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.
Results Reference
background
PubMed Identifier
6754765
Citation
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.
Results Reference
background
PubMed Identifier
15948694
Citation
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.
Results Reference
background
PubMed Identifier
2061423
Citation
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.
Results Reference
background
PubMed Identifier
3162464
Citation
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.
Results Reference
background
PubMed Identifier
158084
Citation
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.
Results Reference
background
PubMed Identifier
1026900
Citation
Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.
Results Reference
background
PubMed Identifier
15948695
Citation
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.
Results Reference
background
PubMed Identifier
14584861
Citation
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.
Results Reference
background
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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
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