Correlation Between Oral Health and Systemic Inflammation (COHESION)

N/ACompletedNCT03641989

Marshfield Clinic Research Foundation112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

112

Conditions

Inflammation Periodontal Disease Gingivitis

Interventions

Plaque disclosing toothpasteOTHER

Plaque identifying toothpaste with a FDA-registered seed-extract dye (Annatto (Bixa Orellana)) and FD\&C Blue No. 1.

Non-plaque disclosing toothpasteOTHER

Toothpaste that does not contain the FDA-registered seed-extract dye (Annatto (Bixa Orellana)) and FD\&C Blue No. 1.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 84 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Marshfield Clinic-Marshfield Center

Marshfield, Wisconsin, United States

Outcomes

Primary Outcomes

Change in hsCRP levels with the use of the assigned toothpaste.

The primary outcome measure is magnitude of change in level of high sensitivity CRP (hsCRP) pre-trial compared to post trial as a surrogate marker to monitor change in local and systemic inflammation. Study eligible subjects with hsCRP levels between 0.5 and 10.0 mg/L at baseline (Visit 1) will be randomized to brushing for 30 days with one of two toothpastes followed by reassessment at visit 3 at the end of the intervention. Since distribution of hsCRP is skewed toward higher values, to satisfy statistical model assumptions, significance of the observed differences in outcomes between groups from baseline to day 30 will be tested on log-transformed data by using ANCOVA with treatment and baseline measurement as main factors and treatment by baseline measurement interaction. All significance tests for hsCRP will be conducted using R version 3.3.1 and two-sided significance levels of 0.05.

Time frame: 30 days

Secondary Outcomes

Bleeding on Probing (BOP

Decrease in number of teeth with BOP following tooth-brushing intervention from baseline visit is a represents a primary clinical indicator of reduction in local inflammation of periodontal tissue. BOP per tooth will be evaluated by a dental professional using a periodontal probe along the gum line of each tooth at 6 sites per tooth at the baseline pre-trial visit (Visit One) and at post trial Visit Three after the 30 day tooth brushing intervention. The outcome measure will be the difference in the number of teeth exhibiting BOP pre and post the 30 day trial. This variable has no units and is a dichotomous nominal variable (i.e yes/no) evaluated on a per-tooth basis across total number of evaluable teeth present in the participant's mouth. (Scoring: 1=BOP present; 0=BOP absent).

Time frame: 30 days

Periodontal Pocket Depth (PPD)

PPD per tooth at 6 sites per tooth as a measure of periodontal health at baseline pre and post use of the assigned toothpaste will be assessed to determine presence and extent of PD. A dental professional will perform a periodontal assessment, pre (Visit one) and post (Visit three) the 30 day tooth brushing intervention applying Periodontology (AAP) 1999 Classification Criteria with 2015 updates to classify extent of PD as a continuous variable. PPD measurement, measured in mm, will be carried out pre and post clinical trial participation using a periodontal probe.

Data from ClinicalTrials.gov

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