Dentine SensitivityNCT02789618
A Pilot Study to Substantiate the Use of the Jay Sensitivity Sensor Probe
A study testing A01, B99 and M89 in people with Dentine Sensitivity, run by Unilever R&D.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentine Sensitivity
- What is being tested?
- A01, B99 and M89
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to 22 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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)
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
- Being tested
- A01, B99, M89
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A01Other
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
B99Other
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.
M89Other
Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days.
| Study group | Role | What they receive |
|---|---|---|
| A01 | Active comparator | Toothpaste containing calcium silicate and Sodium Monofluorophosphate (1450ppm F) and a gel containing sodium fluoride (1450ppm F) Receives: Other: A01 |
| B99 | Active comparator | Toothpaste containing Stannous Fluoride and a dentinal bonding agent Receives: Other: B99 |
| M89 | Placebo comparator | Toothpaste containing sodium fluoride (1450ppm F) Receives: Other: M89 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 18 days, 29 days and 57 days
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
Measured: Baseline, 18 days, 29 days and 57 days
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
Measured: Baseline, 18 days, 29 days and 57 days
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)
Measured: Baseline, 18 days, 29 days and 57 days
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
Measured: Baseline, 18 days, 29 days and 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startOct 2016
- Primary completion22 Dec 2016
- Study completion22 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentine SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pesquisa e Ensino em Saúde, Porto Allegre, Brazil
- Responsible party
- Sponsor
- Investigators
- Sabrina Gomes, Principal investigator, PENSA, Rua Carvalho Monteiro 234/601, Porto Alegre, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789618
- Sponsor's protocol ID
- ORL-SEN-2267
- Status last verified
- May 2016
- First submitted
- 18 May 2016
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02789618
- Acronym / sponsor ID
- ORL-SEN-2267
- Conditions
- Dentine Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Pesquisa e Ensino em Saúde, Porto Allegre, Brazil
- Study start
- Oct 2016 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A01 | Active comparator | Other: A01Toothpaste containing calcium silicate and Sodium Monofluorophosphate (1450ppm F) and a gel containing sodium fluoride (1450ppm F) |
| B99 | Active comparator | Other: B99Toothpaste containing Stannous Fluoride and a dentinal bonding agent |
| M89 | Placebo comparator | Other: M89Toothpaste containing sodium fluoride (1450ppm F) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (32 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A01Subjects 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 | A01 |
| B99Subjects 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 | B99 |
| M89Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days. | Other | M89 |
Primary outcome
Dentin hypersensitivity as measured using the Jay Probe
Time frame: Baseline, 18 days, 29 days and 57 days
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
Time frame: Baseline, 18 days, 29 days and 57 days
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
Time frame: Baseline, 18 days, 29 days and 57 days
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
Time frame: Baseline, 18 days, 29 days and 57 days
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)
Time frame: Baseline, 18 days, 29 days and 57 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Dentine Sensitivity
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A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
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Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina Gomes principal investigator
PENSA, Rua Carvalho Monteiro 234/601, Porto Alegre, Brazil
Questions about this trial
What is this clinical trial studying?
A study testing A01, B99 and M89 in people with Dentine Sensitivity, run by Unilever R&D.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentin hypersensitivity as measured using the Jay Probe (time frame: Baseline, 18 days, 29 days and 57 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2018.