Correlation Between Oral Health and Systemic Inflammation (COHESION)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change in hsCRP levels with the use of the assigned toothpaste.
研究概览
简要总结
COHESION is a randomized trial targeting reduction of systemic inflammation through an oral hygiene regimen incorporating a plaque-disclosing toothpaste and a control toothpaste.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will not be told which toothpaste they have been given.
入排标准
- 年龄范围
- 21 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in hsCRP levels with the use of the assigned toothpaste.
时间窗: 30 days
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.
次要结局
- Overall oral health assessment and analytical plan(30 days)
- Evaluate CD4/CD8 ratio for participants over the age of 45(30 days)
- Bleeding on Probing (BOP(30 days)
- Periodontal Pocket Depth (PPD)(30 days)
- Plaque Levels(30 days)
研究者
Amit Acharya, BDS, MS, PhD
Executive Director
Marshfield Clinic Research Foundation