Correlation Between Oral Health and Systemic Inflammation (COHESION) — COHESION  

Inflammation Clinical Trial

Official title: Correlation Between Oral Health and Systemic Inflammation (COHESION)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Gingivitis
• Inflammation
• Periodontal Disease
• Periodontal Diseases

• NCT number: NCT03641989
• Study type: Interventional
• Source: Marshfield Clinic Research Foundation
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Completion date: December 30, 2019