Correlation Between Oral Health and Systemic Inflammation (COHESION): A Randomized Pilot Follow-Up Trial of a Plaque-Identifying Toothpaste - 31/07/20
Abstract |
Background |
Inflammation is intimately involved in the pathogenesis of atherosclerosis and is accurately measured by high-sensitivity C-reactive protein (hs-CRP), a sensitive marker for future risk of cardiovascular disease. The Correlation between Oral Health and Systemic Inflammation (COHESION) trial was designed to test the hypothesis that PlaqueHD, a plaque-identifying toothpaste, reduces hs-CRP.
Methods |
The trial was designed initially to include 132 subjects with hs-CRP between 2.0 and 10.0 mg/L but instead randomized 112 between 0.5 and 10.0, of which 103 had baseline and follow-up data and comprised the intention-to-treat sample. Of these, a prespecified subgroup analysis included 40 with baseline hs-CRP >2.0 and all hs-CRP <10. Because the distribution of hs-CRP was skewed toward higher values, to achieve normality assumptions, the significance of changes in hs-CRP between groups over time was tested on log-transformed data using a mixed effects analysis of variance.
Results |
The intention-to-treat analysis showed no significant differences between the PlaqueHD and placebo group (P = .615). The prespecified subgroup analysis showed a significant difference between the PlaqueHD and placebo group (P = .047). Results of the analysis showed a reduction in hs-CRP at follow-up of 0.58 in the PlaqueHD and an increase of 0.55 in the placebo group.
Conclusions |
These findings are compatible with those of a prior pilot trial that also suggested benefits only in subjects with baseline elevations. Future trials targeting reductions of hs-CRP levels should randomize subjects with baseline hs-CRP between 2.0 and 10.0 mg/L.
El texto completo de este artículo está disponible en PDF.Keywords : C-reactive protein, Inflammation, Plaque-identifying toothpaste, PlaqueHD
Esquema
| Funding: This investigator initiated research grant was funded by the Marshfield Clinic Research Institute and the University of Wisconsin Institute for Clinical and Translational Research, which is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number UL1TR002373. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The toothpaste and matching placebo were provided by TJA Health, LLC (Joliet, Ill.). Neither the funding source nor the distributor of the toothpaste had any role in the design, conduct, analysis, interpretation, or preparation of the manuscript. Nor did they have a role in the decision where to submit. |
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| Conflict of Interest: AA reports that he receives funds from Delta Dental of Wisconsin Foundation for developing and designing public health tools in dentistry, and royalties for authorship and editorship of 2 textbooks. AA does not own any common or preferred stock in any pharmaceutical or medical device company. IG, SH, and MCT report no disclosures. KK reports that he serves as an independent scientist as a member of data monitoring committees for Astellas, AstraZeneca, Actelion, Bayer, Bristol-Myers Squibb, GlaxoSmithKline, Idorsia, Merck, and Sarepta. KK holds no stock in any biopharmaceutical or medical device company. DLD reports that that he serves as an independent scientist in an advisory role to the National Institutes of Health, the US Food and Drug Administration, and the pharmaceutical and medical device industry on the design, monitoring, and analysis of trials; on data monitoring committees for Duke Clinical Research Institute, Population Health Research Institute at University of Hamilton, Actelion, Bristol-Myers Squibb, Medtronic, Boston Scientific, GlaxoSmithKline, Mesoblast, LivaNova, DalCor, and Merck; and to Frontier Science, Intercept, Sanofi, and D L DeMets Consulting. DLD holds no stock in any pharmaceutical or device company. CHH reports that he serves as an independent scientist in an advisory role to investigators and sponsors as chair of data monitoring committees for Amgen, British Heart Foundation, Cadila, Canadian Institutes of Health Research, DalCor, and Regeneron, and to the US Food and Drug Administration, and UpToDate; receives royalties for authorship or editorship of 3 textbooks and as co-inventor on patents for inflammatory markers and cardiovascular disease that are held by Brigham and Women's Hospital; has an investment management relationship with the West-Bacon Group within SunTrust Investment Services, which has discretionary investment authority; and does not own any common or preferred stock in any pharmaceutical or medical device company. |
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| Authorship: All authors had access to the data and a role in writing this manuscript. |
Vol 133 - N° 8
P. 994-998 - août 2020 Regresar al número
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