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Subjects with at least two teeth with dentinal hypersensitivity and who meet the study criteria will be enrolled onto this double blind, randomised, parallel, controlled clinical trial. After enrolment, suitable subjects will use a fluoride toothpaste for 4 weeks (wash out period). Baseline dentine hypersensitivity assessments will be conducted using tactile stimuli, air blast, and VAS methods. Tactile methods of assessment will include use of the Yeaple Probe and the Jay Sensitivity Sensor probe. Air blast assessments will be conducted using the Schiff cold air sensitivity scale. The Oral Health Impact Profile (OHIP) questionnaire will be completed at four defined time points during the study. The baseline assessments will be conducted on the two teeth identified during the screening visit.
On completion of the baseline assessments, subjects will be randomly assigned to product. Dentinal hypersensitivity assessments will be repeated after 18, 28 and 56 days of product use.
Enrollment
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Inclusion criteria
Exclusion criteria
Individuals with the following conditions will not be eligible for participation in the study:
Subjects who have used anti sensitivity products in the 4 weeks prior to screening
Subjects likely to require the use of professional dentinal desensitising therapy during the study.
Subjects with an active oral ulcer (aphthous ulcer), or have similar experience within past 1 month.
Subjects whose indicator teeth have abnormal oral pathology, for example:
Currently undergoing dental treatment, including orthodontic treatment.
Subjects who had vital bleaching
Investigational teeth are or are likely to become denture abutments during the course of the study.
Known allergies to toothpaste and serum 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, SSRI medication
Severe gingivitis, periodontitis and/or marked tooth mobility.
Gingival surgery in the previous six months.
Subjects with any serious concomitant diseases or medical or psychological conditions.
In the opinion of the investigator unable to comply fully with the trial requirements.
Participation in other dental clinical trials.
Pregnant or breastfeeding (Self-Reported)
Subjects who have participated in an oral care study within the previous 3 months.
Diabetic (both Type 1 and Type 2)
Previous history of rheumatic fever or heart valve pathology or require antibiotics for prophylaxis against bacterial endocarditis.
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.
Use of anticonvulsants; antihistamines; anti-depressants; sedatives; tranquilisers; anti-inflammatory drugs or daily analgesics.
Full or removable partial dentures.
The subject is an employee of Unilever or the site conducting the study.
Primary purpose
Allocation
Interventional model
Masking
137 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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