Dentin SensitivityNCT03244618
A Study to Measure the Efficacy of a Toothpaste on Dentinal Hypersensitivity
A study testing CSSP Toothpaste and Fluoride Toothpaste in people with Dentin Sensitivity, run by Unilever R&D at 1 site in United Kingdom.
Trial summary
Double blind parallel study to measure the efficacy of a toothpaste containing calcium-silicate/phosphate on dentinal hypersensitivity compared to a control toothpaste containing fluoride Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- CSSP Toothpaste and Fluoride Toothpaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jun 2017to 13 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18 years and older.
- Willing and physically able to carry out all study procedures.
- Willing and able to give written informed consent and complete a medical history form.
- Have at least one hypersensitive tooth in two quadrants, which are anterior to the molars and demonstrate cervical dentine, which have an air-blast hypersensitivity score of 2 or 3 on the Schiff sensitivity scale at Screening and Baseline and a tactile hypersensitivity score of 10-20 grams of force at baseline.
- Willing to comply with the oral hygiene and food and drink restrictions.
Who cannot join
- Subjects who have used anti sensitivity products in the 4 weeks prior to screening
- Subjects with an active oral ulcer (Aphthous ulcer), or have similar experience within past 1 month.
- Subjects who use a powered toothbrush at least 4 times a week to brush their teeth
- Subjects whose indicator teeth have abnormal oral pathology, for example:
- Extensive restorations.
- Observable caries.
Show all 28Show fewer
- 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 have had vital bleaching within 4 weeks of the screening visit
- Known allergies to any toothpaste 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, non-steroidal anti-inflammatory drug and selective serotonin reuptake inhibitor medication
- Severe gingivitis, periodontitis and/or marked tooth mobility.
- Gingival surgery in the previous six months.
- In the opinion of the investigator unable to comply fully with the trial requirements.
- Participation in other dental clinical trials in the previous 28 days
- Subjects who have participated in an dentinal hypersensitivity study within the previous 1 month.
- Diabetic (both Type 1 and Type 2)
- 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.
- Smokers or e-cigarette use or those who have smoked/vaped in the previous 12 months
- Brushing < 10 times a week during the Run-In period (self-reported)
- Using <17g or > 53g of toothpaste in a two week period during the test phase
- The subject is an employee of Unilever or the site conducting the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Oral and Dental Science
Bristol, BS1 2LY
About this study
Official title: A Medical Device Study to Measure the Efficacy of a Toothpaste Containing Calcium-silicate/Phosphate on Dentinal Hypersensitivity Compared to a Control Toothpaste Containing Fluoride.
Double blind parallel study to measure the efficacy of a toothpaste containing calcium-silicate/phosphate on dentinal hypersensitivity compared to a control toothpaste containing fluoride
Read the detailed description
This is a double blind parallel design, with respect to the clinical assessor and subject, study. A minimum of 280 (140 per group), male and female subjects will be recruited to ensure that a minimum of 200 subjects (100 per group) complete the study. Subjects will attend the test site on six (6) occasions.
Subjects will be screened according to the inclusion and exclusion criteria. Suitable subjects will be given a standard fluoride toothpaste and a toothbrush to use for the following four to six weeks (Run-in Phase).
On completion of the run in phase, the subjects will have a baseline sensitivity and soft tissue assessments conducted and randomised to product (visit 3).
Subjects will be randomly assigned to the test groups.
Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to use for the following 2 weeks. Instructions for use (IFUs) will be given to the subjects along with a toothbrushing diary and an appointment to return to the test site 2 weeks (+/-1 day) later.
At the Day 14 visit, subjects will have the dentinal hypersensitivity and soft tissue assessments repeated.
Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to use for the following 2 weeks. A fresh toothbrushing diary will be given to the subject along with an appointment to return to the test site 2 weeks later (Week 4 assessment). Subjects will be instructed to brush their teeth as per the IFU for the following 2 weeks.
At the Day 28 visit subjects will have the dentinal hypersensitivity and soft tissue assessments repeated. Prior to leaving the study site, the subjects will be asked to brush their teeth as per the IFU. Subjects will be requested to brush their teeth at a specific time and return to the study site the following day.
At the Day 29 visit, subjects will have the dentinal hypersensitivity and soft tissue assessments repeated. On completion of the assessments, subjects will receive their remuneration for the participating in the study.
- Conditions
- Dentin Sensitivity
- Being tested
- CSSP Toothpaste, Fluoride Toothpaste
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSSP ToothpasteDevice
Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate
Fluoride ToothpasteDevice
Toothpaste containing sodium monofluorphosphate
| Study group | Role | What they receive |
|---|---|---|
| CSSP Toothpaste | Experimental | Toothpaste containing Calcium Silicate and Sodium Phosphate Receives: Device: CSSP Toothpaste |
| Fluoride Toothpaste | Placebo comparator | Toothpaste containing Sodium monofluorphosphate Receives: Device: Fluoride Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermo-evaporative (Schiff Air Blast) Stimuli
Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. HIgher score is worse outcome.
Measured: 4-weeks of product use (Day 28)
Secondary outcomes (2)
Tactile (Yeaple Probe) Stimuli
The Yeaple score is recorded in terms of quantified reproducible force (range 10-60 grams with higher values indicating a better outcome). The Yeaple probe tip with a force of 10 grams is passed over the exposed dentin on the buccal surface of the selected teeth, apical to the cementenamel junction and the applied force in increased each time by 10 grams until the participant indicates that he/she is experiencing discomfort, or until 20 grams (baseline) or 60 grams (post product use) of force is reached. A higher value indicates lower levels of dentinal hypersensitivity. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth.
Measured: 4-weeks of product use (Day 28)
Visual Analogue Scale
Visual Analogue Scale values were recorded to give the outcome variable per subject at the same time asSchiff assessment. The VAS values were assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).
Measured: 4-weeks of product use (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start19 Jun 2017
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Bristol
- Responsible party
- Sponsor
- Investigators
- Nicola X West, Professor, Principal investigator, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244618
- Sponsor's protocol ID
- ORL-SEN-2530
- Status last verified
- Sep 2020
- First submitted
- 18 Jul 2017
- Last updated
- 5 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seong J, Newcombe RG, Matheson JR, Weddell L, Edwards M, West NX. A randomised controlled trial investigating efficacy of a novel toothpaste containing calcium silicate and sodium phosphate in dentine hypersensitivity pain reduction compared to a fluoride control toothpaste. J Dent. 2020 Jul;98:103320. doi: 10.1016/j.jdent.2020.103320. Epub 2020 Jun 1.
PubMed 32497553
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Medical Device Study to Measure the Efficacy of a Toothpaste Containing Calcium-silicate/Phosphate on Dentinal Hypersensitivity Compared to a Control Toothpaste Containing Fluoride.
- ClinicalTrials.gov ID
- NCT03244618
- Acronym / sponsor ID
- ORL-SEN-2530
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- University of Bristol
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Posted 5 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double blind parallel study to measure the efficacy of a toothpaste containing calcium-silicate/phosphate on dentinal hypersensitivity compared to a control toothpaste containing fluoride
Detailed description
This is a double blind parallel design, with respect to the clinical assessor and subject, study. A minimum of 280 (140 per group), male and female subjects will be recruited to ensure that a minimum of 200 subjects (100 per group) complete the study. Subjects will attend the test site on six (6) occasions.
Subjects will be screened according to the inclusion and exclusion criteria. Suitable subjects will be given a standard fluoride toothpaste and a toothbrush to use for the following four to six weeks (Run-in Phase).
On completion of the run in phase, the subjects will have a baseline sensitivity and soft tissue assessments conducted and randomised to product (visit 3).
Subjects will be randomly assigned to the test groups.
Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to use for the following 2 weeks. Instructions for use (IFUs) will be given to the subjects along with a toothbrushing diary and an appointment to return to the test site 2 weeks (+/-1 day) later.
At the Day 14 visit, subjects will have the dentinal hypersensitivity and soft tissue assessments repeated.
Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to use for the following 2 weeks. A fresh toothbrushing diary will be given to the subject along with an appointment to return to the test site 2 weeks later (Week 4 assessment). Subjects will be instructed to brush their teeth as per the IFU for the following 2 weeks.
At the Day 28 visit subjects will have the dentinal hypersensitivity and soft tissue assessments repeated. Prior to leaving the study site, the subjects will be asked to brush their teeth as per the IFU. Subjects will be requested to brush their teeth at a specific time and return to the study site the following day.
At the Day 29 visit, subjects will have the dentinal hypersensitivity and soft tissue assessments repeated. On completion of the assessments, subjects will receive their remuneration for the participating in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSSP Toothpaste | Experimental | Device: CSSP ToothpasteToothpaste containing Calcium Silicate and Sodium Phosphate |
| Fluoride Toothpaste | Placebo comparator | Device: Fluoride ToothpasteToothpaste containing Sodium monofluorphosphate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects aged 18 years and older.
- Willing and physically able to carry out all study procedures.
- Willing and able to give written informed consent and complete a medical history form.
- Have at least one hypersensitive tooth in two quadrants, which are anterior to the molars and demonstrate cervical dentine, which have an air-blast hypersensitivity score of 2 or 3 on the Schiff sensitivity scale at Screening and Baseline and a tactile hypersensitivity score of 10-20 grams of force at baseline.
- Willing to comply with the oral hygiene and food and drink restrictions.
Key exclusion criteria (28 listed)
- Subjects who have used anti sensitivity products in the 4 weeks prior to screening
- Subjects with an active oral ulcer (Aphthous ulcer), or have similar experience within past 1 month.
- Subjects who use a powered toothbrush at least 4 times a week to brush their teeth
- Subjects whose indicator teeth have abnormal oral pathology, for example:
- Currently undergoing dental treatment, including orthodontic treatment.
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 |
|---|---|---|
| CSSP ToothpasteToothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate | Device | CSSP Toothpaste |
| Fluoride ToothpasteToothpaste containing sodium monofluorphosphate | Device | Fluoride Toothpaste |
Primary outcome
Thermo-evaporative (Schiff Air Blast) Stimuli
Time frame: 4-weeks of product use (Day 28)
Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity recorded: 0 = Tooth/Subject does not respond; 1 Tooth/subject responds but does not request discontinuation; 2 Tooth/subject responds and requests discontinuation or moves;3 Tooth/subject responds, considers stimulus to be painful, and requests discontinuation. Each subject will be characterised at each visit by the average of the relevant scores for the two indicator teeth. HIgher score is worse outcome.
2 secondary outcomes
Tactile (Yeaple Probe) Stimuli
Time frame: 4-weeks of product use (Day 28)
Visual Analogue Scale
Time frame: 4-weeks of product use (Day 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32497553Seong J, Newcombe RG, Matheson JR, Weddell L, Edwards M, West NX. A randomised controlled trial investigating efficacy of a novel toothpaste containing calcium silicate and sodium phosphate in dentine hypersensitivity pain reduction compared to a fluoride control toothpaste. J Dent. 2020 Jul;98:103320. doi: 10.1016/j.jdent.2020.103320. Epub 2020 Jun 1.
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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.
Nicola X West, Professor principal investigator
University of Bristol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSSP Toothpaste and Fluoride Toothpaste in people with Dentin Sensitivity, run by Unilever R&D at 1 site in United Kingdom.
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 5 inclusion and 28 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 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Thermo-evaporative (Schiff Air Blast) Stimuli (time frame: 4-weeks of product use (Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03244618, which also lists 1 linked publication.
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 5 Oct 2020.