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:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT04996069
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age.
* The inability to produce more than 0.18mL/min of unstimulated saliva.
* Score of 5 or more in the VAS dry mouth scale, evaluated in the mouth feel questionnaire.
* Evidence of currently taking Xerostomia-inducing medication such as, antihypertensives, anti-anxiety agents, psychiatric remedies, antihistamines.
* Subject not currently using any teeth whitening or desensitizing products that contain potassium nitrate such as Sensodyne or Pronamel.
* Subject willing to comply with the study regimen and products.
Exclusion Criteria
* Subjects who are currently pregnant (self-reported).
* Subjects able to produce more than 0.18mL/min of unstimulated saliva
* Subjects that have ever received therapeutic radiation in the head and neck area.
* Subjects with a diagnosis of conditions that would affect salivary flow such as Sjogren's Syndrome.
* Subjects with a condition the investigator believes not suitable for the study such as autoimmune diseases that impact salivary flow.
* Subjects that currently use whitening toothpaste, desensitizing toothpaste, or any other products causing similar results.
* Subjects currently participating in any other research studies.
* Subject unable to provide consent (ex. Cognitively impaired adults).
* Non-English speaking
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04996069
Study Brief:
Protocol Section:
NCT04996069