Trial of Toothpaste to Reduce Plaque and Inflammation

Inflammation Clinical Trial

Official title:

A Randomized Trial of Plaque Identifying Toothpaste on Reduction of Plaque and Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666508
• Other study ID #: 2015-0620
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: August 22, 2016

Study information

• Verified date: January 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 22, 2016
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Plaque

Intervention

Other:
• Plaque identifying toothpaste
Plaque identifying toothpaste with targetol
• Non-plaque identifying toothpaste
Non-plaque identifying toothpaste without targetol

Locations

Country	Name	City	State
United States	UIC Clinical Research Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Florida Atlantic University

Country where clinical trial is conducted

United States, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 30 - 60 days post baseline
Primary	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.	Baseline to 30 - 60 days post baseline
Secondary	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).	Baseline to 30-60 days post
Secondary	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	Baseline to 30-60 days post

External Links

•   American Heart Association. Heart and Stroke Statistics.
•   Hs-CRP: The test | high-sensitivity C-reactive protein; hs-CRP test: High-sensitivity C-reactive protein | lab tests online.
•   HSRIC: Grants, funding and fellowships.
•   Relationship between serum antibody titres to porphyromonas gingivalis and hs-CRP levels as inflammatory markers of periodontitis.
•   The World Health Organization. Cardiovascular Diseases (CVDs)