Trial of Toothpaste to Reduce Plaque and Inflammation
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 19 - 45 |
| Updated: | 10/14/2017 |
| Start Date: | August 2015 |
| End Date: | April 2016 |
| Contact: | Kimberly Fasula, MS |
| Email: | kfasul1@uic.edu |
| Phone: | 312-996-5513 |
A Randomized Trial of Plaque Identifying Toothpaste on Reduction of Plaque and Inflammation
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.
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.
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.
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.
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
We found this trial at
1
site
Chicago, Illinois 60612
Principal Investigator: Kimberly Fasula, MS
Phone: 312-996-2937
Click here to add this to my saved trials
