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
About this trial
This is an interventional other trial for Dentine Sensitivity
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.
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
NCT ID
NCT02789618
First Posted
May 18, 2016
Last Updated
June 6, 2018
Sponsor
Unilever R&D
Collaborators
Pesquisa e Ensino em Saúde, Porto Allegre, Brazil
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