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 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT03244618
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03244618
Study Brief:
Protocol Section:
NCT03244618