Clinical trial NCT02666508: Trial of Toothpaste to Reduce Plaque and Inflammation
Official title: A Randomized Trial of Plaque Identifying Toothpaste on Reduction of Plaque and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque
Inflammation
Keywords: plaque identifying toothpaste
plaque score
C-reactive protein
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Florida Atlantic University
First posted: 2016-01-28
Enrollment: 61
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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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

Primary outcomes:
measure: Change in Oral Plaque
timeFrame: Baseline to 30 - 60 days post baseline
measure: Change in Hs-CRP Serum Level
timeFrame: Baseline to 30 - 60 days post baseline
Secondary outcomes:
measure: Change in Oral Plaque - PSS Analysis
timeFrame: Baseline to 30-60 days post
measure: Change in Inflammation - PSS Analysis
timeFrame: Baseline to 30-60 days post
Other outcomes:
Locations:
city: Chicago
country: United States
facility: UIC Clinical Research Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Kimberly Fasula, MS
role: PRINCIPAL_INVESTIGATOR
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