Trial of Toothpaste to Reduce Plaque and Inflammation

January 11, 2021 updated by: Kim Fasula, University of Illinois at Chicago

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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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Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • UIC Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Plaque identifying toothpaste
A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol
Other: Plaque identifying toothpaste
Plaque identifying toothpaste with targetol
Active Comparator: Non-plaque identifying toothpaste
A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol
Other: Non-plaque identifying toothpaste
Non-plaque identifying toothpaste without targetol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oral Plaque
Time Frame: Baseline to 30 - 60 days post baseline
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.
Baseline to 30 - 60 days post baseline
Change in Hs-CRP Serum Level
Time Frame: Baseline to 30 - 60 days post baseline
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.
Baseline to 30 - 60 days post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oral Plaque - PSS Analysis
Time Frame: Baseline to 30-60 days post
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).
Baseline to 30-60 days post
Change in Inflammation - PSS Analysis
Time Frame: Baseline to 30-60 days post
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
Baseline to 30-60 days post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

Florida Atlantic University

Investigators

  • Principal Investigator: Kimberly Fasula, MS, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

August 22, 2016

Study Registration Dates

First Submitted

January 24, 2016

First Submitted That Met QC Criteria

January 24, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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