Correlation Between Oral Health and Systemic Inflammation (COHESION)

The present pilot trial will test the hypothesis that regular brushing with Plaque HD
(interventional toothpaste) compared to conventional toothpaste (control) for 30 days in
participants with confirmed mild to severe PD will significantly reduce hsCRP levels, a
sensitive marker of inflammation and predictor of CVD. By completing the COHESION trial, we
will collect important and relevant data to support application for investigator-initiated
research funding from the US National Institutes of Health to directly test whether Plaque HD
reduces CVD in larger, scaled multi-center randomized trial.

Participants will be asked to participate in three visits. During Visit One, we will be
reviewing their medical and dental information as well as performing an oral evaluation to
determine their level of gingivitis or periodontal disease. If the participant remains
eligible, their blood will be drawn to determine whether the baseline hsCRP level falls
within the eligible range (≥0.5 to ≤10.0 mg/L).

During Visit Two, if the participant remains eligible, they will be randomized and given a
30-day supply of the interventional or control toothpaste along with a study diary to track
their progress.

The participant will receive a follow-up call 15 days after Visit Two to track compliance
with study activity and monitor for any adverse events.

30-days later, during Visit Three, the participants will undergo another oral evaluation in
addition to a second blood draw to measure the hsCRP level after using their assigned
toothpaste for 30 days.

Inclusion Criteria:

- Willing and able to provide written informed consent

- Speak and understand English

- Willing and able to comply with all procedures for the duration of the trial

- ≥ 12 natural teeth

- Baseline hs-CRP level ≥0.5 and ≤10.0 mg/L

- No exposure to statins

- Presence of dental provider assessed gingivitis or mild, moderate or severe
periodontitis based on the American Academy of Periodontology (AAP) and presence of
visible plaque/calculus

Exclusion Criteria:

- Diagnosis or history of atherosclerosis, myocardial infarction, stroke, transient
ischemic attack, peripheral vascular disease

- History of inflammatory conditions such as rheumatoid arthritis, lupus or other
chronic inflammatory condition; cancer

- Exposure to statins

- Consistent or prescribed use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS)
or immunosuppressive drugs (defined as 10 or more doses in past 30 days)

- Removable appliances only if gum inflammation is present where the appliance is seated

- Dental prophylaxis [e.g., cleaning, scaling or root planning to mechanically remove
plaque and calculus] within 30 days of randomization

- Infection anywhere in the body 2 weeks prior to baseline visit (excluding presence of
PD) or exposure to antibiotics or anti-viral agents during this time frame

- Trauma to oral cavity within two weeks of baseline visit

- Current tobacco use

- Women who are pregnant or breast-feeding

- Use of any investigational products within 30 days of randomization

- History of allergies to dyes

- Deemed not suitable for study participation based on the clinical judgment of the
investigator