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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 272
- Locations
- 2
- Primary Endpoint
- Thermo-evaporative (Schiff Air Blast) Stimuli
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Tactile (Yeaple Probe) Stimuli(4-weeks of product use (Day 28))
- Visual Analogue Scale(4-weeks of product use (Day 28))