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 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 12:11 AM
NCT ID:
NCT01307358
Eligibility Criteria:
Inclusion Criteria:
* are in good/excellent health
* are 18 - 70 years old
* have abstained from all oral care in the 12 hours prior to their scheduled appointment, but no more than 18 hours prior
* have abstained from consumption of apples and other sticky fruits in the 12 hours prior to their appointment
* have a minimum of 20 natural teeth (excluding 3rd molars)
* have 2 qualifying Interproximal Unit test sites in each posterior quadrant from 3 approximating teeth : The following are the IU test site qualifiers:
* Each IU test site shall consist of two adjacent teeth with un-restored interproximal surfaces with a closed contact. (Note: restorations are permissible if they do not interfere with plaque and GCF sampling as determined by examiner discretion)
* IU test sites of choice are as follows in the order of preference:
* Molar/premolar
* Premolar/premolar
* Molar/molar
* molar/canine
* have PPD ≤ 4mm at all four sites within each interproximal unit test site
* have ≥ 20 bleeding sites (whole mouth) as determined by the Gingival Bleeding Index
* have provided written informed consent and are willing to participate and be available at all times required for participation
* are willing and able to fully understand and comply with the written and verbal study instructions provided in English
* agree to return all study materials at the final visit
Exclusion Criteria:
* have systemic diseases, Down's syndrome, or known AIDS/HIV;
* Have Diabetes
* are a smoker
* are pregnant or nursing by subject report;
* have a cardiac pacemaker or AICD
* are undergoing or require extensive dental or orthodontic treatment;
* have had oral or gum surgery in the previous 2 months;
* require antibiotic treatment for dental appointments;
* have used antibiotics within 4 weeks of enrollment
* are currently using prescription-dose anti-inflammatory medications or anticoagulants (including aspirin)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01307358
Study Brief:
Protocol Section:
NCT01307358