A Pilot Study to Substantiate the Use of the Jay Sensitivity Sensor Probe

This is an interventional other trial for Dentine Sensitivity Read More

Inclusion Criteria:

• Willing and physically able to carry out all study procedures.
• Willing to give written informed consent and complete a medical history form.
• Have one hypersensitive tooth in two quadrants with exposed roots, which are anterior to the molars and demonstrate cervical erosion/abrasion or gingival recession, which have an air-blast hypersensitivity score of 2 or 3 on the Schiff sensitivity scale at Screening and a tactile hypersensitivity score of 10-60 grams of force using the Yeaple probe at baseline.
• Willing to comply with the oral hygiene and food and drink restrictions.

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:

  • Extensive restoration.
  • 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 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.