Clinical trial NCT03690479: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Diagnoses Disease
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Florida Probe Corporation
First posted: 2018-10-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: VAS (visual analogue scale) value 0-100mm
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida College of Dentistry
state: Florida
Study officials:
affiliation: School of Dental Science - Trinity College Dublin
name: Peter Harrison, DMD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
citation: Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.
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.
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.