Inflammation Clinical Trial
Official title:
Correlation Between Oral Health and Systemic Inflammation (COHESION)
COHESION is a randomized trial targeting reduction of systemic inflammation through an oral hygiene regimen incorporating a plaque-disclosing toothpaste and a control toothpaste.
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.
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