Correlation Between Oral Health and Systemic Inflammation (COHESION)

Completed · Not applicable

Conditions studied: Inflammation, Periodontal Disease, Gingivitis

In brief

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

Key facts

Study ID

NCT03641989

Run by

Marshfield Clinic Research Foundation

People needed

112

Starts

2018-09-17

Expected to finish

2019-12-30

Last updated by the study team

2020-02-20

Who can join

Age: 21 and older, up to 84. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Marshfield Clinic-Marshfield Center — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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