Trial of Toothpaste to Reduce Plaque & Inflammation

Status Completed

Clinical Trial 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.

Clinical Trial 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. . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02666508
Study type	Interventional
Source	University of Illinois at Chicago
Contact
Status	Completed
Phase	N/A
Start date	September 1, 2015
Completion date	August 22, 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Trial of Toothpaste to Reduce Plaque and Inflammation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms