Trial of Toothpaste to Reduce Plaque and Inflammation

NCT02666508 | Completed Results

• 1 other identifier: 2015-0620
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plaque; Inflammation

Keywords

plaque identifying toothpaste; plaque score; C-reactive protein

Outcome Measures

Primary Outcomes (2)

• Change in Oral Plaque

  Measure description "percentage" refers to the change in plaque percentage from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline.

  Baseline to 30 - 60 days post baseline

• Change in Hs-CRP Serum Level

  Measure description "mg/L" refers to the change in hs-CRP per mg/L from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline.

  Baseline to 30 - 60 days post baseline

Secondary Outcomes (2)

• Change in Oral Plaque - PSS Analysis

  Baseline to 30-60 days post

• Change in Inflammation - PSS Analysis

  Baseline to 30-60 days post

Study Arms (2)

Plaque identifying toothpaste

ACTIVE COMPARATOR

A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol

Other: Plaque identifying toothpaste

Non-plaque identifying toothpaste

ACTIVE COMPARATOR

A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol

Other: Non-plaque identifying toothpaste

Interventions

Plaque identifying toothpaste OTHER

Plaque identifying toothpaste with targetol

Plaque identifying toothpaste

Non-plaque identifying toothpaste OTHER

Non-plaque identifying toothpaste without targetol

Non-plaque identifying toothpaste

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Florida Atlantic University: collaborator

Study Sites (1)

UIC Clinical Research Center

Chicago, Illinois, 60612, United States

Location

Related Publications (35)

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  BACKGROUND

• Harnacke D, Winterfeld T, Erhardt J, Schlueter N, Ganss C, Margraf-Stiksrud J, Deinzer R. What is the best predictor for oral cleanliness after brushing? Results from an observational cohort study. J Periodontol. 2015 Jan;86(1):101-7. doi: 10.1902/jop.2014.140152.

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• Stevens K, Belavsky B, Evans CA, Viana MG, Wu C. Evaluation of plaque removal efficacy of a novel dye-containing toothpaste: a clinical trial. Int J Dentistry Oral Sci. 2016; 3(1):185-189

  BACKGROUND

Related Links

• The World Health Organization. Cardiovascular Diseases (CVDs)
• American Heart Association. Heart and Stroke Statistics.
• Relationship between serum antibody titres to porphyromonas gingivalis and hs-CRP levels as inflammatory markers of periodontitis.
• Hs-CRP: The test \| high-sensitivity C-reactive protein; hs-CRP test: High-sensitivity C-reactive protein \| lab tests online.
• HSRIC: Grants, funding and fellowships.

MeSH Terms

Conditions

Plaque, Amyloid; Inflammation

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Limitations and Caveats

Funding limited the study to a small number of subjects. Funding also limited options to compensate subject as a method to pre-select subjects with elevated hs-CRP.

Results Point of Contact

• Title: Kimberly Fasula RDH, MS, MPH
• Organization: UIC College of Dentistry

kfasul1@uic.edu

(312) 996-5513

Study Officials

• Kimberly Fasula, MS

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinic Operations & Clinical Instructor, College of Dentistry

Study Record Dates

• First Submitted: January 24, 2016
• First Posted: January 28, 2016
• Study Start: September 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: August 22, 2016
• Last Updated: January 14, 2021
• Results First Posted: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)