Randomized Trial of Plaque Identifying Toothpaste: Dental Plaque and Inflammation

Warren Han, Mercer University College of Pharmacy

Inflammation has been determined to play a major role in atherothrombosis. The utilization of inflammatory markers such as high sensitivity c-reactive protein (hs-CRP) may provide a novel method for detecting individuals at high risk of cardiovascular plaque rupture. [1]  It has been shown that hs-CRP is a strong, independent predictor of future myocardial infarction and stroke. [2]

Dental plaque is an overgrowth of the mouth’s natural bacterial flora on our teeth. Upon improper cleaning, bacteria can feed on leftover sugars and build up into plaque. Plaque releases acid which breaks down the integrity of a tooth’s hard enamel and may lead to cavities, infections, and inflammation. [3]

Randomized Trial of Plaque Identifying Toothpaste: Dental Plaque and Inflammation [4]
Design Randomized trial; N= 61
Objective To test the superiority of Plaque HD over placebo toothpaste in reducing dental plaque
Study Groups Plaque HD (n= 31); placebo (n= 30)
Methods Healthy subjects aged 19 to 44 years old used a fluorescein mouth rinse and intraoral photographs were taken under black light imaging, and a digital plaque analysis was done. Custom software was used to calculate mean plaque ratios: (plaque pixels) / (plaque + teeth pixels) x 100%. Changes in hs-CRP in milligrams per liter were assessed by Quest Laboratories using an enzyme linked immunosorbent assay. Intention to treat (ITT) was used for dental plaque analysis, and a pre-specified subgroup (PSS) was used for hs-CRP because there was no prescreen for elevated levels. In the PSS only patients with baseline plaque ratios > 0.5 and ≤ 10.0, and follow up ≤ 60 days were included.
Duration 60 days
Primary Outcome Measure Changes in dental plaque between baseline and follow-up and changes in hs-CRP.
Baseline Characteristics Intention to Treat Pre-specified subgroup (PSS)
Demographic Placebo Plaque HD p-value Placebo Plaque HD p-value
Mean age, yrs 27.1 28.4 0.439 26.9 30.0 0.200
Female, n (%) 18 (60.0%) 16 (51.6%) 0.688 11 (57.9%) 11 (57.9%) > 0.999
African American, n 5 (16.7%) 6 (19.4%) N/A 1 (5.3%) 3 (15.8%) 0.874
Asian, n 10 (33.3%) 13 (41.9%) N/A 6 (31.6%) 6 (31.6%) 0.874
Hispanic, n 7 (23.3%) 4 (12.9%) N/A 5 (26.3%) 4 (21.1%) 0.874
White, n 8 (26.7%) 8 (25.8%) N/A 7 (36.8%) 6 (31.6%) 0.874
Results Baseline Follow up Mean ratio
Placebo Plaque HD p-value Placebo Plaque HD p-value Placebo Plaque HD p-value
Plaque ratios ITT 7.46 10.24 0.083 5.68 5.20 0.273 0.76 0.51 0.001
hs-CRP, milligrams per liter ITT 2.47 2.31 0.657 4.47 2.18 0.306 1.81 0.94 0.459
PSS 2.32 3.13 0.352 2.89 2.22 0.377 1.25 0.71 0.041
Adverse Events Common Adverse Events: N/A
Serious Adverse Events: N/A
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions This plaque identifying toothpaste produced statistically significant reductions in dental plaque and hs-CRP.  More studies with a sufficient size and duration are needed, but the current results may have major clinical and public health implications

 

In this study of the efficacy of Plaque HD the population size was small and the duration of time studied was short which does not predict long-term efficacy.  The direct connection between the use of Plaque HD and reductions in hs-CRP were difficult to find, because patients were not screened at baseline for elevated hs-CRP.  A bias may exist because this study was funded as an investigator initiated research grant by TJA Health, LLC, which manufactures Plaque HD.  The conclusion that Plaque HD does reduce levels of hs-CRP may prove useful in further research correlating oral health to cardiovascular disease.

References

  1. Ridker PM. High-sensitivity C-reactive protein: potential adjunct for global risk assessment in the primary prevention of cardiovascular disease. Circulation. 2001;103(13):1813-8.
  2. Mendall MA, Strachan DP, Butland BK, et al. C-reactive protein: relation to total mortality, cardiovascular mortality and cardiovascular risk factors in men. Eur Heart J. 2000;21:1584–1590.
  3. Mayo Clinic Staff. Organic foods: Cavities/tooth decay. The Mayo Clinic. http://www.mayoclinic.org/diseases-conditions/cavities/basics/causes/con-20030076 Published May 30, 2014. Accessed November 7, 2016.
  4. Fasula K, Evans CA, Boyd L, et al. Randomized trial of Plaque identifying Toothpaste: Dental Plaque and Inflammation. Am J Med. 2016.

 

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