Status:
COMPLETED
A Study to Measure the Efficacy of a Toothpaste on Dentinal Hypersensitivity
Lead Sponsor:
Unilever R&D
Collaborating Sponsors:
University of Bristol
Conditions:
Dentin Sensitivity
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2018
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT03244618
Start Date
June 19 2017
End Date
June 13 2018
Last Update
October 5 2020
Active Locations (1)
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1
School of Oral and Dental Science
Bristol, United Kingdom, BS1 2LY