Clinical trial NCT03641989: Correlation Between Oral Health and Systemic Inflammation (COHESION)
Official title: Correlation Between Oral Health and Systemic Inflammation (COHESION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Periodontal Disease
Gingivitis
Keywords: Toothpaste
Inflammation
Periodontal Disease
hsCRP
Oral health
Oral hygiene
Lead sponsor: Marshfield Clinic Research Foundation
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
First posted: 2018-08-22
Enrollment: 112
Sex: ALL
Minimum age (years): 21
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to brush twice daily for 30 days with the plaque disclosing agent toothpaste or a reference, non-plaque disclosing toothpaste. Toothpastes are comparable based on equivalent content of the active ingredient: fluoride.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in hsCRP levels with the use of the assigned toothpaste.
timeFrame: 30 days
Secondary outcomes:
measure: Bleeding on Probing (BOP
timeFrame: 30 days
measure: Periodontal Pocket Depth (PPD)
timeFrame: 30 days
measure: Plaque Levels
timeFrame: 30 days
measure: Overall oral health assessment and analytical plan
timeFrame: 30 days
measure: Evaluate CD4/CD8 ratio for participants over the age of 45
timeFrame: 30 days
Other outcomes:
Locations:
city: Marshfield
country: United States
facility: Marshfield Clinic-Marshfield Center
state: Wisconsin
Study officials:
affiliation: Marshfield Clinic Research Institute
name: Amit Acharya, BDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
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