NCT02666508

Trial of Toothpaste to Reduce Plaque and Inflammation

A Randomized Trial of Plaque Identifying Toothpaste on Reduction of Plaque and Inflammation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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.

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. .

Conditions

• Plaque
• Inflammation

Interventions

Type	Name	Description
OTHER	Plaque identifying toothpaste	Plaque identifying toothpaste with targetol
OTHER	Non-plaque identifying toothpaste	Non-plaque identifying toothpaste without targetol

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-04-01
• Completion: 2016-08-22
• First posted: 2016-01-28
• Last updated: 2021-01-14
• Results posted: 2021-01-14

Locations

1 site across 1 country: United States