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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT04596761
Eligibility Criteria:
Inclusion Criteria
1. Adult subjects aged 18 years and older, that are in good health.
2. Subject must have a minimum of 16 natural teeth, including six mandibular anterior teeth with no crowns or veneers.
3. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
4. The subjects should be willing to comply with the study procedures and schedule, including the follow up visits.
5. Subjects must demonstrate a propensity for calculus formation as evidenced by at least 9 mm of calculus on the lingual surfaces of the six mandibular teeth, following the 2-month run-in phase.
Exclusion Criteria
1. Subjects who had a medical condition requiring antibiotic premedication prior to dental procedures.
2. Regular users of a chlorhexidine mouthrinse.
3. Any oral condition or pathosis that could interfere with study compliance and/or examination procedures (e.g., widespread caries, chronic neglect, advanced periodontal dis-ease).
4. Current or history of oral cavity cancer or oropharyngeal cancer.
5. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
6. Pregnant or nursing by subject report.
7. Subjects that do not brush regularly.
8. Any condition that might make 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
Study:
NCT04596761
Study Brief:
Protocol Section:
NCT04596761