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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT06139835
Eligibility Criteria:
Inclusion Criteria:
In order to be included in the study, each subject must have:
1. Provided written informed consent to participate in the study;
2. Adult subjects aged 18 years and older, that were in good health;
3. Agreed not to participate in any other oral/dental product studies during the course of this study and used only the assigned oral hygiene products during the entire study (including toothbrushes, toothpastes, home remedies, floss or other products like chewing gum, mouthwashes, tongue cleaners, etc.);
4. Agreed to refrain from the use of any elective dentistry (including a non-study dental prophylaxis) until the study had been completed;
5. Agreed to refrain from the use of any non-study oral hygiene and whitening products;
6. Been in good general health, as determined by the investigator/designee based on a review of the health history/update for participation in the study;
7. Had six mandibular anterior teeth with no crowns or veneers;
8. Agreed to comply with the study procedures and schedule, including the follow up visits;
9. Had at least 9mm of dental calculus on the mandibular anterior six teeth and reported that they had received a dental cleaning in previous 2-6 months.
10. Healthy Volunteers
Exclusion Criteria:
1. Had a medical condition requiring antibiotic premedication prior to dental procedures;
2. Regularly used chlorhexidine mouth rinse;
3. Had any oral condition or pathosis that could interfere with study compliance and/or examination procedures (e.g., widespread caries, chronic neglect, advanced periodontal disease);
4. Had current or history of oral cavity cancer or oropharyngeal cancer;
5. Were pregnant or nursing by subject report;
6. Did not brush regularly;
7. Had any condition that might have made it unsafe for the subject to participate in this study, at the discretion of the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06139835
Study Brief:
Protocol Section:
NCT06139835