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N/A N=61 Randomized Single-blind Treatment

Trial of Toothpaste to Reduce Plaque and Inflammation

Plaque · Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT02666508 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change in Oral Plaque — -1.05; -0.03 log(percentage) — p=0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Plaque identifying toothpaste (Other); Non-plaque identifying toothpaste (Other)
Age
Adult · 19+ yrs
Sex
All
Sponsor
University of Illinois at Chicago
Primary completion
Apr 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Oral Plaque		 -1.05; -0.03 0.001 sig
PRIMARY
Change in Hs-CRP Serum Level		 0.04; 0.22 0.459
SECONDARY
Change in Oral Plaque - PSS Analysis		 -1.05; -0.10 —
SECONDARY
Change in Inflammation - PSS Analysis		 -0.40; 0.14 —

Summary

Dental plaque causes caries and periodontal disease and data are sparse about toothpaste and plaque removal. Inflammation, caused by dental plaque, is a risk factor for cardiovascular disease. (CVD) The availability of (Plaque HD (TM), a plaque identifying toothpaste with targetol technology (TM)), afforded the unique opportunity to test whether there were statistically significant and clinically important reductions in plaque and inflammation in a randomized trial of apparently healthy individuals.

Eligibility Criteria

Inclusion Criteria

The inclusion criteria were as follows:

  • Apparently healthy men and women age 19-45 with no history of CVD
  • All 12 anterior teeth present (canine to canine in both upper and lower arches)
  • English speaking
  • Ability to commit to two 30 minute appointments These appointment must be 1 month apart)

Exclusion Criteria

  • • Student, faculty or staff with a clinical role at the University of Illinois College of Dentistry
  • Individuals taking aspirin, other non-steroidal anti-inflammatory drugs or statins.
  • Women who are pregnant or nursing
  • Women taking birth control pills or using any hormone released birth control device
  • Women on hormone replacement therapy
  • Individuals who have taken antibiotics within two weeks of data collection appointment
  • Individuals experiencing xerostomia
  • Individuals who have experienced an illness, infection or tissue injury within two weeks of data collection appointment
  • Individuals with arthritis, lupus or other chronic inflammatory conditions or syndromes
  • Individuals with allergies to dyes or over the counter products
  • Individuals who have missing anterior teeth, fixed or removable appliances or visible decay or staining in the anterior region (canine to canine in both upper and lower arches)
  • Individuals whom have had a dental prophylaxis within 30 days of the data collection visit
  • Individuals who have had a new restoration placed (anywhere in the oral cavity) within 30 days of the data collection visit
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02666508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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