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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT04218994
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Subjects must show \> 20% interproximal sites (mesial facial and mesial lingual and distal facial and distal lingual) with BoP. This includes mesial and distal sites next to edentulous areas.
* Subjects must have \> 24 natural teeth including teeth with crowns with margins confluent with the natural tooth as long as they do not violate the biologic width.
* Third molars will be excluded from study; unless the third molars are in the anatomical position of second molars. However, subjects with third molars present will be accepted into the study unless there are other factors that exclude them.
* Subjects must report having had a professional dental prophylaxis within four months of beginning the study.
* Subjects must be willing to floss daily and to be taught and use a specific technique of flossing.
Exclusion Criteria:
* Subjects who use tobacco products.
* Subjects with fixed or removable orthodontic appliances
* Subjects with splinted fixed prostheses.
* Subjects who are incapable of flossing their teeth
* Subjects with defective interproximal restorations or interproximal caries that are clinically evident and impacting gingival health.
* Subjects where malposed teeth preclude the use of floss
* Subjects with probing depth greater than or equal to 5mm.
* Subjects who are pregnant (self-reported) due to the greater bleeding tendency due to the hormonal changes.
* Subjects with a systemic disease that affects the gingiva or are taking medications of which affect the gingiva.
* Non-English speaking subjects, as study assessments and instructions will be in English only. There is no direct benefit to subjects for taking part in this study, therefore the exclusion of non-English speaking subjects is not an ethical concern.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04218994
Study Brief:
Protocol Section:
NCT04218994