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

NCT02789618 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2018-06-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Pesquisa e Ensino em Saúde, Porto Allegre, Brazil

    collaborator UNKNOWN

  • Unilever R&D

    lead INDUSTRY

Principal Investigators

  • Sabrina Gomes · PENSA, Rua Carvalho Monteiro 234/601, Porto Alegre, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2016-12-22
Completion
2016-12-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02789618 on ClinicalTrials.gov