NCT03641989

Correlation Between Oral Health and Systemic Inflammation (COHESION)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Marshfield Clinic Research Foundation · Academic / Other
• Sex: All
• Age: 21 Years – 84 Years
• Healthy volunteers: Accepted

Summary

COHESION is a randomized trial targeting reduction of systemic inflammation through an oral hygiene regimen incorporating a plaque-disclosing toothpaste and a control toothpaste.

Detailed description

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.

Conditions

• Inflammation
• Periodontal Disease
• Gingivitis

Interventions

Type	Name	Description
OTHER	Plaque disclosing toothpaste	Plaque identifying toothpaste with a FDA-registered seed-extract dye (Annatto (Bixa Orellana)) and FD\&C Blue No. 1.
OTHER	Non-plaque disclosing toothpaste	Toothpaste that does not contain the FDA-registered seed-extract dye (Annatto (Bixa Orellana)) and FD\&C Blue No. 1.

Timeline

• Start date: 2018-09-17
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2018-08-22
• Last updated: 2020-02-20

Locations

1 site across 1 country: United States