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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT06561204
Eligibility Criteria:
Inclusion Criteria:
* University of Minnesota School of Dentistry patient of record who is 18 years of age or older.
* Documented periodontal classification of mild to moderate gingivitis (\>10% BOP) or documented gingivitis on an intact, reduce, or stable with a history of periodontitis in AxiUm electronic health record (EHR) \>10% BOP.
* A minimum of 25% plaque measured O'Leary plaque score.
* A minimum of five natural teeth in each quadrant (excluding third molars, dental implants or teeth with more that ½ of natural surface restored).
* Be willing to abstain from all professional oral hygiene care (prophy/periodontal maintenance) during the study.
* Be willing to abstain from the use of any other dental cleaning aids (dental floss, water flossers, interdental brushes, dental or tooth picks, mouthwash, etc.) during the study.
* Access to personal email account and a device connected to the internet to complete questionnaires and communicate with study team.
Exclusion Criteria:
* Presence of aggressive, necrotizing, uncommon periodontal disease, or any uncontrolled periodontal condition.
* Presence of any physical limitation or restriction that might preclude normal oral hygiene procedures (i.e. need another individual to perform oral self-care).
* Fixed prosthesis (i.e. implant retained denture), orthodontic appliance or under orthodontic treatment.
* Any medication that may impact periodontal conditions (i.e., phenytoin, calcium antagonists, cyclosporin, warfarin, antimicrobials, or steroids).
* Have any uncontrolled medical condition or immunocompromised that may impact the study (i.e. uncontrolled diabetes HbA1c \> 7, HIV).
* Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)
* ≥2 weeks of antibiotic use in the past three months. Or antibiotic use in the last six weeks.
* Cigarette use within the last year
* Unable to comply with the study protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06561204
Study Brief:
Protocol Section:
NCT06561204