Dentin Sensitivity
Conditions
Brief 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
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.
Interventions
DEVICECSSP Toothpaste
Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate
DEVICEFluoride Toothpaste
Toothpaste containing sodium monofluorphosphate
Sponsors
University of Bristol
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thermo-evaporative (Schiff Air Blast) Stimuli | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tactile (Yeaple Probe) Stimuli | 4-weeks of product use (Day 28) | 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. |
| Visual Analogue Scale | 4-weeks of product use (Day 28) | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Thermo-evaporative (Schiff Air Blast) Stimuli | Day 29, 12 hours after product use has ceased | Air blast sensitivity assessed by directing a one-second blast of air onto the exposed buccal root surface of sensitive tooth. Sensitivity will be 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. |
| Tactile (Yeaple Probe) Stimuli | Day 29, 12 hours after product use has ceased | 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. |
| Visual Analogue Scale | Day 29, 12 hours after product use has ceased | Visual Analogue Scale values of the same teeth will be also be recorded to give the outcome variable per subject at the same time of Schiff assessment. The VAS values will be assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain). |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited at a single center in Bristol, United Kingdom.
Pre-assignment details
Participants brushed for 4-6 weeks with fluoride toothpaste during run-in period between enrollment and randomization. 272 participants were enrolled out of which 263 were randomized. Reasons for participant not being randomized: * Did not meet Baseline inclusion criteria (n=1) * Withdrawal by subject (n=6) * Lost to follow-up (n=2)
Participants by arm
| Arm | Count |
|---|---|
| CSSP Toothpaste Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds. | 132 |
| Fluoride Toothpaste Toothpaste containing sodium monofluorphosphate. Participants were asked to brush for two minutes with the toothpaste twice per day, morning and evening, using their normal routine. After the evening brush, partipants were instructed to massage a pea sized amount of the toothpaste into the sensitive surfaces of the two selected sensitive teeth for 30 seconds. | 131 |
| Total | 263 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Protocol Violation | 4 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | CSSP Toothpaste | Fluoride Toothpaste | Total |
|---|---|---|---|
| Age, Continuous | 34.4 years STANDARD_DEVIATION 12.7 | 37.4 years STANDARD_DEVIATION 13.5 | 35.9 years STANDARD_DEVIATION 13.2 |
| Race/Ethnicity, Customized Asian | 13 Participants | 16 Participants | 29 Participants |
| Race/Ethnicity, Customized Black | 10 Participants | 11 Participants | 21 Participants |
| Race/Ethnicity, Customized Caucasian | 106 Participants | 104 Participants | 210 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 0 Participants | 3 Participants |
| Region of Enrollment United Kingdom | 132 participants | 131 participants | 263 participants |
| Sex: Female, Male Female | 72 Participants | 71 Participants | 143 Participants |
| Sex: Female, Male Male | 60 Participants | 60 Participants | 120 Participants |
| Thermo-evaporative (Schiff air blast) stimuli | 2.193 units on a scale STANDARD_DEVIATION 0.336 | 2.256 units on a scale STANDARD_DEVIATION 0.336 | 2.224 units on a scale STANDARD_DEVIATION 0.337 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 132 | 0 / 131 |
| other Total, other adverse events | 2 / 132 | 4 / 131 |
| serious Total, serious adverse events | 0 / 132 | 0 / 131 |
Outcome results
Primary
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.
Time frame: 4-weeks of product use (Day 28)
Population: Analysis was based on all available data at week 4 from subjects who were randomised
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSSP Toothpaste | Thermo-evaporative (Schiff Air Blast) Stimuli | Baseline | 2.188 score on a scale | Standard Deviation 0.334 |
| CSSP Toothpaste | Thermo-evaporative (Schiff Air Blast) Stimuli | Week 4 | 1.268 score on a scale | Standard Deviation 0.723 |
| Fluoride Toothpaste | Thermo-evaporative (Schiff Air Blast) Stimuli | Baseline | 2.246 score on a scale | Standard Deviation 0.329 |
| Fluoride Toothpaste | Thermo-evaporative (Schiff Air Blast) Stimuli | Week 4 | 1.811 score on a scale | Standard Deviation 0.624 |
p-value: <0.00195% CI: [-0.712, -0.377]ANOVA
Secondary
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.
Time frame: 4-weeks of product use (Day 28)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSSP Toothpaste | Tactile (Yeaple Probe) Stimuli | Baseline | 17.5 score on a scale | Standard Deviation 3.46 |
| CSSP Toothpaste | Tactile (Yeaple Probe) Stimuli | Week 4 | 38.2 score on a scale | Standard Deviation 14.4 |
| Fluoride Toothpaste | Tactile (Yeaple Probe) Stimuli | Baseline | 16.6 score on a scale | Standard Deviation 3.75 |
| Fluoride Toothpaste | Tactile (Yeaple Probe) Stimuli | Week 4 | 27.5 score on a scale | Standard Deviation 11.7 |
p-value: <0.00195% CI: [7.5, 14]ANOVA
Secondary
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).
Time frame: 4-weeks of product use (Day 28)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSSP Toothpaste | Visual Analogue Scale | Baseline | 48.1 score on a scale | Standard Deviation 20.5 |
| CSSP Toothpaste | Visual Analogue Scale | Week 4 | 31.1 score on a scale | Standard Deviation 22.8 |
| Fluoride Toothpaste | Visual Analogue Scale | Baseline | 49.9 score on a scale | Standard Deviation 19.8 |
| Fluoride Toothpaste | Visual Analogue Scale | Week 4 | 42.0 score on a scale | Standard Deviation 22.1 |
p-value: <0.00195% CI: [-16.4, -5.5]ANOVA
Other Pre-specified
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.
Time frame: Day 29, 12 hours after product use has ceased
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSSP Toothpaste | Tactile (Yeaple Probe) Stimuli | Baseline | 17.5 score on a scale | Standard Deviation 3.46 |
| CSSP Toothpaste | Tactile (Yeaple Probe) Stimuli | Day 29, 12hr after last product use | 41.5 score on a scale | Standard Deviation 14.2 |
| Fluoride Toothpaste | Tactile (Yeaple Probe) Stimuli | Baseline | 16.6 score on a scale | Standard Deviation 3.75 |
| Fluoride Toothpaste | Tactile (Yeaple Probe) Stimuli | Day 29, 12hr after last product use | 29.7 score on a scale | Standard Deviation 11.9 |
p-value: <0.00195% CI: [8.6, 15.1]ANOVA
Other Pre-specified
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 will be 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.
Time frame: Day 29, 12 hours after product use has ceased
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSSP Toothpaste | Thermo-evaporative (Schiff Air Blast) Stimuli | Baseline | 2.188 score on a scale | Standard Deviation 0.334 |
| CSSP Toothpaste | Thermo-evaporative (Schiff Air Blast) Stimuli | Day 29, 12hr after last product use | 1.044 score on a scale | Standard Deviation 0.773 |
| Fluoride Toothpaste | Thermo-evaporative (Schiff Air Blast) Stimuli | Baseline | 2.246 score on a scale | Standard Deviation 0.329 |
| Fluoride Toothpaste | Thermo-evaporative (Schiff Air Blast) Stimuli | Day 29, 12hr after last product use | 1.713 score on a scale | Standard Deviation 0.671 |
p-value: <0.00195% CI: [-0.85, -0.489]ANOVA
Other Pre-specified
Visual Analogue Scale
Visual Analogue Scale values of the same teeth will be also be recorded to give the outcome variable per subject at the same time of Schiff assessment. The VAS values will be assigned a numerical value in the conventional order from 0 (no pain) to 100 (extremely pain).
Time frame: Day 29, 12 hours after product use has ceased
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSSP Toothpaste | Visual Analogue Scale | Baseline | 48.1 score on a scale | Standard Deviation 20.5 |
| CSSP Toothpaste | Visual Analogue Scale | Day 29, 12hr after last product use | 27.2 score on a scale | Standard Deviation 23.2 |
| Fluoride Toothpaste | Visual Analogue Scale | Baseline | 49.9 score on a scale | Standard Deviation 19.8 |
| Fluoride Toothpaste | Visual Analogue Scale | Day 29, 12hr after last product use | 38.1 score on a scale | Standard Deviation 22.7 |
p-value: <0.00195% CI: [-16.6, -5.2]ANOVA