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 @ 4:53 PM
Ignite Modification Date:
2025-12-24 @ 4:53 PM
NCT ID:
NCT04059250
Eligibility Criteria:
Inclusion Criteria:
* aged between 18 and 80 years,
* have at least six natural teeth remaining and have a recent history of dental caries
* wearing lower partial denture (with replaced teeth on both sides of the mouth)
* willing to wear their denture during the night
* are in good health, of either gender
* are in good current oral health with no active caries or periodontal disease (but with a history of caries)
* have an understanding of the study
* have saliva flow within the normal range (stimulated saliva flow rate of greater than 0.7 ml/minute)
* no antibiotics for the last three months
* willing to comply with all study procedures and protocols,
* residing in San Francisco or other nearby locales with community water fluoridation (to eliminate water fluoridation as a potential confounding variable)
* able to give written consent themselves
* must be able to read and understand English
* willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form; data will only be used for research
Exclusion Criteria:
* subjects who have less than 6 natural teeth remaining
* subjects who have used a 5,000 ppm fluoride toothpaste in the last 6 months
* subjects who have used Chlorhexidine or any other antimicrobials (cetylpyridinium etc.) in the last 6 months
* show evidence of extremely poor oral hygiene
* subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis)
* taking medications that may affect the oral flora or salivary flow (e.g. antibiotic use in the past three months, drugs associated with dry mouth / xerostomia)
* other conditions that may decrease the likelihood of adhering to study protocol
* in-office fluoride treatment within the last three months
* subjects who will leave the area and are unable to complete the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04059250
Study Brief:
Protocol Section:
NCT04059250