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

NCT03690479 | Completed DMC

• 1 other identifier: 244-2011
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Diagnoses Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ball Tip Probe

ACTIVE COMPARATOR

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

Florida Probe Straight Tip Probe

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Standard Tip Probe

Florida Probe Straight 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.

Also known as: Titanium Tip Probe

Ball Tip Probe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years.
• Must have 4 tooth sites with periodontal probing pocket depth (PPD) greater or equal to 4mm.

You may not qualify if:

• \- Daily use of analgesic medications (NSAIDs etc) for over 3 months.

Sponsors & Collaborators

• University of Florida: lead
• Florida Probe Corporation: collaborator

Study Sites (1)

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

Location

Related Publications (9)

• 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.

  PMID: 17576606 BACKGROUND

• 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.

  PMID: 6754765 BACKGROUND

• 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.

  PMID: 15948694 BACKGROUND

• 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.

  PMID: 2061423 BACKGROUND

• 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.

  PMID: 3162464 BACKGROUND

• 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.

  PMID: 158084 BACKGROUND

• Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.

  PMID: 1026900 BACKGROUND

• 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.

  PMID: 15948695 BACKGROUND

• 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.

  PMID: 14584861 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Peter Harrison, DMD

  School of Dental Science - Trinity College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 1, 2018
• Study Start: April 4, 2013
• Primary Completion: September 6, 2014
• Study Completion: December 14, 2017
• Last Updated: October 2, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)