NCT02789618

A Pilot Study to Substantiate the Use of the Jay Sensitivity Sensor Probe

A Pilot Study to Substantiate the Use of the Jay Sensitivity Sensor Probe by Correlating the Results With the Those of Yeaple Probe, Schiff Air Blast, Visual Analogue Scale (VAS) and Oral Health Impact Profile Questionnaire (OHIP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Subjects with at least two teeth with dentinal hypersensitivity and who meet the study criteria will be enrolled onto this double blind, randomised, parallel, controlled clinical trial. After enrolment, suitable subjects will use a fluoride toothpaste for 4 weeks (wash out period). Baseline dentine hypersensitivity assessments will be conducted using tactile stimuli, air blast, and VAS methods. Tactile methods of assessment will include use of the Yeaple Probe and the Jay Sensitivity Sensor probe. Air blast assessments will be conducted using the Schiff cold air sensitivity scale. The Oral Health Impact Profile (OHIP) questionnaire will be completed at four defined time points during the study. The baseline assessments will be conducted on the two teeth identified during the screening visit. On completion of the baseline assessments, subjects will be randomly assigned to product. Dentinal hypersensitivity assessments will be repeated after 18, 28 and 56 days of product use.

Conditions

• Dentine Sensitivity

Interventions

Type	Name	Description
OTHER	A01	Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days. The gel will be applied in the evening of three consecutive days during the study time period
OTHER	B99	Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days. The bonding agent will be professional applied immediately prior to the clinical assessments.
OTHER	M89	Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days.

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-12-22
• Completion: 2016-12-22
• First posted: 2016-06-03
• Last updated: 2018-06-08