search
Back to results

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

Primary Purpose

Dentine Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A01
B99
M89
Sponsored by
Unilever R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dentine Sensitivity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Willing and physically able to carry out all study procedures.
  • Willing to give written informed consent and complete a medical history form.
  • Have one hypersensitive tooth in two quadrants with exposed roots, which are anterior to the molars and demonstrate cervical erosion/abrasion or gingival recession, which have an air-blast hypersensitivity score of 2 or 3 on the Schiff sensitivity scale at Screening and a tactile hypersensitivity score of 10-60 grams of force using the Yeaple probe at baseline.
  • Willing to comply with the oral hygiene and food and drink restrictions.

Exclusion Criteria:

Individuals with the following conditions will not be eligible for participation in the study:

  • Subjects who have used anti sensitivity products in the 4 weeks prior to screening
  • Subjects likely to require the use of professional dentinal desensitising therapy during the study.
  • Subjects with an active oral ulcer (aphthous ulcer), or have similar experience within past 1 month.
  • Subjects whose indicator teeth have abnormal oral pathology, for example:

    • Extensive restoration.
    • Observable caries.
    • Observable cracked enamel.
    • Leaking fillings or other restorations.
    • Cracked Tooth Syndrome
    • Suspected pulp pathology/abscess/pulpitis.
    • Atypical facial pain
    • Any tooth surface adjacent to those surfaces under investigation, which in the opinion of the investigator have any other condition(s) that provide confusing symptoms to those of cervical dentine hypersensitivity.
  • Currently undergoing dental treatment, including orthodontic treatment.
  • Subjects who had vital bleaching
  • Investigational teeth are or are likely to become denture abutments during the course of the study.
  • Known allergies to toothpaste and serum ingredients, including the flavour components.
  • Obvious physical disability reducing tooth brushing ability.
  • Receiving concomitant medication/therapy that might affect dentine hypersensitivity, e.g. regular use of analgesics, anti-histamines, SSRI medication
  • Severe gingivitis, periodontitis and/or marked tooth mobility.
  • Gingival surgery in the previous six months.
  • Subjects with any serious concomitant diseases or medical or psychological conditions.
  • In the opinion of the investigator unable to comply fully with the trial requirements.
  • Participation in other dental clinical trials.
  • Pregnant or breastfeeding (Self-Reported)
  • Subjects who have participated in an oral care study within the previous 3 months.
  • Diabetic (both Type 1 and Type 2)
  • Previous history of rheumatic fever or heart valve pathology or require antibiotics for prophylaxis against bacterial endocarditis.
  • Medical condition(s) and/or regular use of any medication, which either could affect the scientific validity of the study or if the subject was to participate in the study could, affect their wellbeing.
  • Use of anticonvulsants; antihistamines; anti-depressants; sedatives; tranquilisers; anti-inflammatory drugs or daily analgesics.
  • Full or removable partial dentures.
  • The subject is an employee of Unilever or the site conducting the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    A01

    B99

    M89

    Arm Description

    Toothpaste containing calcium silicate and Sodium Monofluorophosphate (1450ppm F) and a gel containing sodium fluoride (1450ppm F)

    Toothpaste containing Stannous Fluoride and a dentinal bonding agent

    Toothpaste containing sodium fluoride (1450ppm F)

    Outcomes

    Primary Outcome Measures

    Dentin hypersensitivity as measured using the Jay Probe
    Reduction in pain caused by dentin hypersensitivity will be measured using the Jay Probe (Tactile Stimulation) on day 18, day 29 and day 57 and compared to the baseline measurement
    Dentin hypersensitivity as measured using the Yeaple Probe
    Reduction in pain caused by dentin hypersensitivity will be measured using the Yeaple Probe (Tactile Stimulation) on day 18, day 29 and day 57 and compared to the baseline measurement
    Dentin hypersensitivity measured using the Schiff assessment
    Reduction in pain caused by dentin hypersensitivity will be measured using the Schiff assessment (Air Stimulation) on day 18, day 29 and day 57 and compared to the baseline measurement
    An assessment of dentin hypersensitivity using the OHIP quality of life questionnaire
    Specific quality of life attributes and the impact of dentin hypersensitivity on subject's daily life will be measured (subjective measure)
    Dentin hypersensitivity measured using the visual analogue scale (VAS)
    Reduction in pain caused by dentin hypersensitivity will be measured using the Visual Analogue Scale (VAS) on day 18, day 29 and day 57 and compared to the baseline measurement

    Secondary Outcome Measures

    Full Information

    First Posted
    May 18, 2016
    Last Updated
    June 6, 2018
    Sponsor
    Unilever R&D
    Collaborators
    Pesquisa e Ensino em Saúde, Porto Allegre, Brazil
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02789618
    Brief Title
    A Pilot Study to Substantiate the Use of the Jay Sensitivity Sensor Probe
    Official Title
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    December 22, 2016 (Actual)
    Study Completion Date
    December 22, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Unilever R&D
    Collaborators
    Pesquisa e Ensino em Saúde, Porto Allegre, Brazil

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dentine Sensitivity

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    137 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A01
    Arm Type
    Active Comparator
    Arm Description
    Toothpaste containing calcium silicate and Sodium Monofluorophosphate (1450ppm F) and a gel containing sodium fluoride (1450ppm F)
    Arm Title
    B99
    Arm Type
    Active Comparator
    Arm Description
    Toothpaste containing Stannous Fluoride and a dentinal bonding agent
    Arm Title
    M89
    Arm Type
    Placebo Comparator
    Arm Description
    Toothpaste containing sodium fluoride (1450ppm F)
    Intervention Type
    Other
    Intervention Name(s)
    A01
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    B99
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    M89
    Intervention Description
    Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days.
    Primary Outcome Measure Information:
    Title
    Dentin hypersensitivity as measured using the Jay Probe
    Description
    Reduction in pain caused by dentin hypersensitivity will be measured using the Jay Probe (Tactile Stimulation) on day 18, day 29 and day 57 and compared to the baseline measurement
    Time Frame
    Baseline, 18 days, 29 days and 57 days
    Title
    Dentin hypersensitivity as measured using the Yeaple Probe
    Description
    Reduction in pain caused by dentin hypersensitivity will be measured using the Yeaple Probe (Tactile Stimulation) on day 18, day 29 and day 57 and compared to the baseline measurement
    Time Frame
    Baseline, 18 days, 29 days and 57 days
    Title
    Dentin hypersensitivity measured using the Schiff assessment
    Description
    Reduction in pain caused by dentin hypersensitivity will be measured using the Schiff assessment (Air Stimulation) on day 18, day 29 and day 57 and compared to the baseline measurement
    Time Frame
    Baseline, 18 days, 29 days and 57 days
    Title
    An assessment of dentin hypersensitivity using the OHIP quality of life questionnaire
    Description
    Specific quality of life attributes and the impact of dentin hypersensitivity on subject's daily life will be measured (subjective measure)
    Time Frame
    Baseline, 18 days, 29 days and 57 days
    Title
    Dentin hypersensitivity measured using the visual analogue scale (VAS)
    Description
    Reduction in pain caused by dentin hypersensitivity will be measured using the Visual Analogue Scale (VAS) on day 18, day 29 and day 57 and compared to the baseline measurement
    Time Frame
    Baseline, 18 days, 29 days and 57 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Willing and physically able to carry out all study procedures. Willing to give written informed consent and complete a medical history form. Have one hypersensitive tooth in two quadrants with exposed roots, which are anterior to the molars and demonstrate cervical erosion/abrasion or gingival recession, which have an air-blast hypersensitivity score of 2 or 3 on the Schiff sensitivity scale at Screening and a tactile hypersensitivity score of 10-60 grams of force using the Yeaple probe at baseline. Willing to comply with the oral hygiene and food and drink restrictions. Exclusion Criteria: Individuals with the following conditions will not be eligible for participation in the study: Subjects who have used anti sensitivity products in the 4 weeks prior to screening Subjects likely to require the use of professional dentinal desensitising therapy during the study. Subjects with an active oral ulcer (aphthous ulcer), or have similar experience within past 1 month. Subjects whose indicator teeth have abnormal oral pathology, for example: Extensive restoration. Observable caries. Observable cracked enamel. Leaking fillings or other restorations. Cracked Tooth Syndrome Suspected pulp pathology/abscess/pulpitis. Atypical facial pain Any tooth surface adjacent to those surfaces under investigation, which in the opinion of the investigator have any other condition(s) that provide confusing symptoms to those of cervical dentine hypersensitivity. Currently undergoing dental treatment, including orthodontic treatment. Subjects who had vital bleaching Investigational teeth are or are likely to become denture abutments during the course of the study. Known allergies to toothpaste and serum ingredients, including the flavour components. Obvious physical disability reducing tooth brushing ability. Receiving concomitant medication/therapy that might affect dentine hypersensitivity, e.g. regular use of analgesics, anti-histamines, SSRI medication Severe gingivitis, periodontitis and/or marked tooth mobility. Gingival surgery in the previous six months. Subjects with any serious concomitant diseases or medical or psychological conditions. In the opinion of the investigator unable to comply fully with the trial requirements. Participation in other dental clinical trials. Pregnant or breastfeeding (Self-Reported) Subjects who have participated in an oral care study within the previous 3 months. Diabetic (both Type 1 and Type 2) Previous history of rheumatic fever or heart valve pathology or require antibiotics for prophylaxis against bacterial endocarditis. Medical condition(s) and/or regular use of any medication, which either could affect the scientific validity of the study or if the subject was to participate in the study could, affect their wellbeing. Use of anticonvulsants; antihistamines; anti-depressants; sedatives; tranquilisers; anti-inflammatory drugs or daily analgesics. Full or removable partial dentures. The subject is an employee of Unilever or the site conducting the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sabrina Gomes
    Organizational Affiliation
    PENSA, Rua Carvalho Monteiro 234/601, Porto Alegre, Brazil
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs