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Trial of Toothpaste to Reduce Plaque and Inflammation

Primary Purpose

Plaque, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plaque identifying toothpaste
Non-plaque identifying toothpaste
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque focused on measuring plaque identifying toothpaste, plaque score, C-reactive protein

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UIC Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Plaque identifying toothpaste

Non-plaque identifying toothpaste

Arm Description

A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol

A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol

Outcomes

Primary Outcome Measures

Change in Oral Plaque
Measure description "percentage" refers to the change in plaque percentage from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline.
Change in Hs-CRP Serum Level
Measure description "mg/L" refers to the change in hs-CRP per mg/L from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline.

Secondary Outcome Measures

Change in Oral Plaque - PSS Analysis
Measure description "percentage" refers to the change in plaque percentage from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline for the Pre-Specified Subgroup (PSS).
Change in Inflammation - PSS Analysis
Measure description "mg/L" refers to the change in hs-CRP per mg/L from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline. -PSS analysis

Full Information

First Posted
January 24, 2016
Last Updated
January 11, 2021
Sponsor
University of Illinois at Chicago
Collaborators
Florida Atlantic University
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1. Study Identification

Unique Protocol Identification Number
NCT02666508
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
April 1, 2016 (Actual)
Study Completion Date
August 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Florida Atlantic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Rinse for 10 seconds with 25 mL of phosphate buffer Rinse for 1 minute with 5.0 mL of 1240-ppm fluorescein in phosphate buffer Rinse 3 times (for 10 seconds) with 25mL of phosphate buffer 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. Provide a blood sample for hs-CRP. 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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Inflammation
Keywords
plaque identifying toothpaste, plaque score, C-reactive protein

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plaque identifying toothpaste
Arm Type
Active Comparator
Arm Description
A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol
Arm Title
Non-plaque identifying toothpaste
Arm Type
Active Comparator
Arm Description
A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol
Intervention Type
Other
Intervention Name(s)
Plaque identifying toothpaste
Intervention Description
Plaque identifying toothpaste with targetol
Intervention Type
Other
Intervention Name(s)
Non-plaque identifying toothpaste
Intervention Description
Non-plaque identifying toothpaste without targetol
Primary Outcome Measure Information:
Title
Change in Oral Plaque
Description
Measure description "percentage" refers to the change in plaque percentage from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline.
Time Frame
Baseline to 30 - 60 days post baseline
Title
Change in Hs-CRP Serum Level
Description
Measure description "mg/L" refers to the change in hs-CRP per mg/L from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline.
Time Frame
Baseline to 30 - 60 days post baseline
Secondary Outcome Measure Information:
Title
Change in Oral Plaque - PSS Analysis
Description
Measure description "percentage" refers to the change in plaque percentage from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline for the Pre-Specified Subgroup (PSS).
Time Frame
Baseline to 30-60 days post
Title
Change in Inflammation - PSS Analysis
Description
Measure description "mg/L" refers to the change in hs-CRP per mg/L from the baseline to the follow-up visit. The follow-up visit occurred between 30 and 60 days post baseline. -PSS analysis
Time Frame
Baseline to 30-60 days post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Fasula, MS
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
UIC Clinical Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Trial of Toothpaste to Reduce Plaque and Inflammation

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