Correlation Between Oral Health and Systemic Inflammation (COHESION)

NCT03641989 | Completed

• 1 other identifier: ACH10317
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Periodontal Disease; Gingivitis

Keywords

Toothpaste; Inflammation; Periodontal Disease; hsCRP; Oral health; Oral hygiene

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (5)

• Bleeding on Probing (BOP

  30 days

• Periodontal Pocket Depth (PPD)

  30 days

• Plaque Levels

  30 days

• Overall oral health assessment and analytical plan

  30 days

• Evaluate CD4/CD8 ratio for participants over the age of 45

  30 days

Study Arms (2)

Plaque disclosing toothpaste

ACTIVE COMPARATOR

Based on a randomization schema, a 30 day supply of the plaque disclosing toothpaste will be distributed to the participant. Participants will be instructed to brush two times a day for 30 days with the plaque disclosing toothpaste; avoiding the use of mouth rinses and floss. They will also be instructed to avoid any dental prophylaxis (e.g., cleaning, scaling or root planing to mechanically remove plaque and calculus) while on the trial and 30 days before they are enrolled.

Other: Plaque disclosing toothpaste

Non-plaque disclosing toothpaste

PLACEBO COMPARATOR

Based on a randomization schema, a 30 day supply of the over-the-counter, non-plaque disclosing toothpaste will be distributed to the participant. Participants will be instructed to brush two times a day for 30 days with the plaque disclosing toothpaste; avoiding the use of mouth rinses and floss. They will also be instructed to avoid any dental prophylaxis (e.g., cleaning, scaling or root planing to mechanically remove plaque and calculus) while on the trial and 30 days before they are enrolled.

Other: Non-plaque disclosing toothpaste

Interventions

Plaque disclosing toothpaste OTHER

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

Plaque disclosing toothpaste

Non-plaque disclosing toothpaste OTHER

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

Non-plaque disclosing toothpaste

Eligibility Criteria

• Age: 21 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Marshfield Clinic Research Foundation: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Marshfield Clinic-Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (10)

• Eke PI, Dye BA, Wei L, Slade GD, Thornton-Evans GO, Borgnakke WS, Taylor GW, Page RC, Beck JD, Genco RJ. Update on Prevalence of Periodontitis in Adults in the United States: NHANES 2009 to 2012. J Periodontol. 2015 May;86(5):611-22. doi: 10.1902/jop.2015.140520. Epub 2015 Feb 17.

  PMID: 25688694 BACKGROUND

• Glurich I, Acharya A, Shukla SK, Nycz GR, Brilliant MH. The oral-systemic personalized medicine model at Marshfield Clinic. Oral Dis. 2013 Jan;19(1):1-17. doi: 10.1111/j.1601-0825.2012.01921.x. Epub 2012 Mar 28.

  PMID: 22458294 BACKGROUND

• Ridker PM, Cushman M, Stampfer MJ, Tracy RP, Hennekens CH. Inflammation, aspirin, and the risk of cardiovascular disease in apparently healthy men. N Engl J Med. 1997 Apr 3;336(14):973-9. doi: 10.1056/NEJM199704033361401.

  PMID: 9077376 BACKGROUND

• Demmer RT, Trinquart L, Zuk A, Fu BC, Blomkvist J, Michalowicz BS, Ravaud P, Desvarieux M. The influence of anti-infective periodontal treatment on C-reactive protein: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2013 Oct 14;8(10):e77441. doi: 10.1371/journal.pone.0077441. eCollection 2013.

  PMID: 24155956 BACKGROUND

• Anitha V, Nair S, Shivakumar V, Shanmugam M, Priya BM, Rajesh P. Estimation of high sensitivity C-reactive protein in patients with periodontal disease and without coronary artery disease. Indian J Dent Res. 2015 Sep-Oct;26(5):500-3. doi: 10.4103/0970-9290.172048.

  PMID: 26672420 BACKGROUND

• Ajwani S, Mattila KJ, Narhi TO, Tilvis RS, Ainamo A. Oral health status, C-reactive protein and mortality--a 10 year follow-up study. Gerodontology. 2003 Jul;20(1):32-40. doi: 10.1111/j.1741-2358.2003.00032.x.

  PMID: 12926749 BACKGROUND

• VanWormer JJ, Acharya A, Greenlee RT, Nieto FJ. Oral hygiene and cardiometabolic disease risk in the survey of the health of Wisconsin. Community Dent Oral Epidemiol. 2013 Aug;41(4):374-84. doi: 10.1111/cdoe.12015. Epub 2012 Oct 29.

  PMID: 23106415 BACKGROUND

• Fasula K, Evans CA, Boyd L, Giblin L, Belavsky BZ, Hetzel S, McBride P, DeMets DL, Hennekens CH. Randomized Trial of Plaque-Identifying Toothpaste: Decreasing Plaque and Inflammation. Am J Med. 2017 Jun;130(6):746-749. doi: 10.1016/j.amjmed.2016.09.003. Epub 2016 Oct 19.

  PMID: 27771276 BACKGROUND

• Henson BS, Wong DT. Collection, storage, and processing of saliva samples for downstream molecular applications. Methods Mol Biol. 2010;666:21-30. doi: 10.1007/978-1-60761-820-1_2.

  PMID: 20717775 BACKGROUND

• Lim Y, Totsika M, Morrison M, Punyadeera C. The saliva microbiome profiles are minimally affected by collection method or DNA extraction protocols. Sci Rep. 2017 Aug 17;7(1):8523. doi: 10.1038/s41598-017-07885-3.

  PMID: 28819242 BACKGROUND

Related Links

• Wisconsin Department of Health Services. Deaths.
• Cornell University. Cardiovascular Disease in the United States: Economic Impacts
• Department of Health and Human Services (US). Sacher D. Oral health in America: a report of the Surgeon General. Rockville (MD): HHS, Office of the Surgeon General (US); 2000
• Salimetrics. Saliva Collection and Handling Advice. 3rd Edition. 2015.

MeSH Terms

Conditions

Inflammation; Periodontal Diseases; Gingivitis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Officials

• Amit Acharya, BDS, MS, PhD

  Marshfield Clinic Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told which toothpaste they have been given.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: August 22, 2018
• Study Start: September 17, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

US (1)