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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT02401360
Eligibility Criteria:
Inclusion Criteria:
* give written informed consent prior to their participation;
* be 18 to 65 years of age at the time of enrollment;
* agree not to participate in any other oral/dental product studies;
* agree to delay any elective dentistry (including a dental prophylaxis);
* agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study;
* agree to return for the scheduled visits and follow study procedures;
* be in good general health as determined by the investigator/designee based on a review of the health history/update for participation in the study;
* have more than 10 bleeding sites at visits 1-3
* Consistency of bleeding site number at baseline may be considered;
* have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and
* refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment.
Exclusion Criteria:
* teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus
* antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam
* medical conditions that the investigator considers significant and that may compromise the evaluation of study results
* currently participating in any other clinical trial
* participated in a clinical trial for plaque/gingivitis within the previous 30 days
* pregnant or lactating
* orthodontic appliances or removable partial dentures
* soft or hard tissue tumor of the oral cavity
* advanced periodontal disease
* history of hepatitis, diabetes, or other communicable diseases
* history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
* history of significant adverse effects following the use of oral hygiene products such as toothpaste
* oral pathoses that could interfere with compliance and/or examinations or that need treatment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02401360
Study Brief:
Protocol Section:
NCT02401360