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Trial of Toothpaste to Reduce Plaque and Inflammation

This study is currently recruiting participants.
Verified January 2016 by Kim Fasula, University of Illinois at Chicago
Sponsor:
ClinicalTrials.gov Identifier:
NCT02666508
First Posted: January 28, 2016
Last Update Posted: January 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Florida Atlantic University
Information provided by (Responsible Party):
Kim Fasula, University of Illinois at Chicago
  Purpose
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.

Condition Intervention
Plaque Inflammation Other: Plaque identifying toothpaste Other: Non-plaque identifying toothpaste

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Plaque Identifying Toothpaste on Reduction of Plaque and Inflammation

Further study details as provided by Kim Fasula, University of Illinois at Chicago:

Primary Outcome Measures:
  • Reduction in oral plaque [ Time Frame: 30 days ]
    mean plaque score

  • Inflammation [ Time Frame: 30 day ]
    hs-CRP serum level


Estimated Enrollment: 60
Study Start Date: August 2015
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plaque identifying toothpaste
A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol
Other: Plaque identifying toothpaste
Plaque identifying toothpaste with targetol
Active Comparator: Non-plaque identifying toothpaste
A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol
Other: Non-plaque identifying toothpaste
Non-plaque identifying toothpaste without targetol

Detailed Description:

The protocol was approved by the Institutional Review Board of the University of Illinois and the trial was posted on ClinicalTrials.gov. We screened all potentially eligible subjects from the Medical District of the University of Illinois which includes the Colleges of Dentistry, Medicine, Public Health and Pharmacy.

All willing and eligible subjects signed informed consent forms and were instructed to refrain from brushing or flossing teeth, using any oral hygiene aids (such as mouthwash or chewing gum) the evening prior to and the morning of the data collection appointment. All subjects were be asked to complete the following procedures:

  1. Rinse for 10 seconds with 25 mL of phosphate buffer
  2. Rinse for 1 minute with 5.0 mL of 1240-ppm fluorescein in phosphate buffer
  3. Rinse 3 times (for 10 seconds) with 25mL of phosphate buffer
  4. Be positioned on a tripod chin rest 15 inches in front of the camera, retraction placed and intraoral images captured under UV LED light imaging.
  5. Provide a blood sample for hs-CRP.
  6. Use a 30 day supply of their assigned toothpaste and were instructed to follow the same brushing protocol for the entire month as well as a brushing diary to assist in recording daily participation.

The identical procedures were repeated at the 30 day follow up visit.. In addition, the Plaque HD group was instructed to brush in front of a mirror for 1 minute and to concentrate on removing all visible dye. The placebo group was asked to brush their teeth for 1 minute in front of a mirror, using the provided manual toothbrush.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666508


Contacts
Contact: Kimberly Fasula, MS 312-996-5513 kfasul1@uic.edu

Locations
United States, Illinois
UIC Clinical Research Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Maryann Holtcamp, RN, APN    312-996-2937    mholt@uic.edu   
Principal Investigator: Kimberly Fasula, MS         
Sponsors and Collaborators
University of Illinois at Chicago
Florida Atlantic University
Investigators
Principal Investigator: Kimberly Fasula, MS University of Illinois at Chicago
  More Information

Additional Information:
Publications:
Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. Erratum in: Circulation. 2016 Feb 23;133(8):e417. Circulation. 2015 Jun 16;131(24):e535.
Cusumano CA. Periodontal disease associated with an increased CRP in chronic hemodialysis patients. Rev Nefrol Dial Trans. 2013; 33:188-195.
Mani A, Vadvadgi V, Anarthe R, Saini R, Mani S. A clinical study on Dental Air Force Cleaning System on adult chronic periodontits and its assessment to C-reactive protein levels. Int J Exp Dent Sci. 2012; 1:14-18.
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

Responsible Party: Kim Fasula, Director of Clinic Operations & Clinical Instructor, College of Dentistry, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02666508     History of Changes
Other Study ID Numbers: 2015-0620
First Submitted: January 24, 2016
First Posted: January 28, 2016
Last Update Posted: January 28, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kim Fasula, University of Illinois at Chicago:
plaque identifying toothpaste
plaque score
C-reactive protein

Additional relevant MeSH terms:
Inflammation
Pathologic Processes