Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-25 @ 4:36 AM
NCT ID:
NCT02789618
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02789618
Study Brief:
Protocol Section:
NCT02789618