Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
61 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-09-01
Study Completion Date
2016-08-22
Brief Summary
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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.
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Detailed Description
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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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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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Conditions
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Plaque
Inflammation
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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Plaque identifying toothpaste
A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol
Group Type
ACTIVE_COMPARATOR
Plaque identifying toothpaste
Intervention Type
OTHER
Plaque identifying toothpaste with targetol
Non-plaque identifying toothpaste
A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol
Group Type
ACTIVE_COMPARATOR
Non-plaque identifying toothpaste
Intervention Type
OTHER
Non-plaque identifying toothpaste without targetol
Interventions
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Plaque identifying toothpaste
Plaque identifying toothpaste with targetol
Intervention Type
OTHER
Non-plaque identifying toothpaste
Non-plaque identifying toothpaste without targetol
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
* 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
Minimum Eligible Age
19 Years
Maximum Eligible Age
45 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Florida Atlantic University
OTHER
Sponsor Role
collaborator
University of Illinois at Chicago
OTHER
Sponsor Role
lead
Responsible Party
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Kim Fasula
Director of Clinic Operations & Clinical Instructor, College of Dentistry
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Kimberly Fasula, MS
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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UIC Clinical Research Center
Chicago, Illinois, United States
Site Status
Countries
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United States
References
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Related Links
Access external resources that provide additional context or updates about the study.
http://www.who.int/cardiovascular_diseases/en/
The World Health Organization. Cardiovascular Diseases (CVDs)
http://www.heart.org/HEARTORG/General/Heart-and-Stroke-Association-Statistics_UCM_319064_SubHomePage.jsp.
American Heart Association. Heart and Stroke Statistics.
http://www.sciencedirect.com.proxy.cc.uic.edu/science/article/pii/S0003996911003876
Relationship between serum antibody titres to porphyromonas gingivalis and hs-CRP levels as inflammatory markers of periodontitis.
http://labtestsonline.org/understanding/analytes/hscrp/tab/test
Hs-CRP: The test \| high-sensitivity C-reactive protein; hs-CRP test: High-sensitivity C-reactive protein \| lab tests online.
http://www.nlm.nih.gov/hsrinfo/grantsites.html
HSRIC: Grants, funding and fellowships.
Other Identifiers
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2015-0620
Identifier Type: -
Identifier Source: org_study_id
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