A Study to Measure the Efficacy of a Toothpaste on Dentinal Hypersensitivity

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Device: CSSP Toothpaste
* Device: Fluoride Toothpaste


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSSP Toothpaste<br>Toothpaste containing Calcium Silicate and Sodium Phosphate | Device: CSSP Toothpaste<br>* Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate<br>|
| Placebo Comparator: Fluoride Toothpaste<br>Toothpaste containing Sodium monofluorphosphate | Device: Fluoride Toothpaste<br>* Toothpaste containing sodium monofluorphosphate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4-weeks of product use (Day 28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 4-weeks of product use (Day 28) |