Trial of Toothpaste to Reduce Plaque and Inflammation

Not Applicable

Completed

Conditions: Inflammation
Plaque

Interventions: Other: Non-plaque identifying toothpaste
Other: Plaque identifying toothpaste

Registration Number: NCT02666508

Lead Sponsor: University of Illinois at Chicago

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:

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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-plaque identifying toothpaste	Non-plaque identifying toothpaste	A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol
Plaque identifying toothpaste	Plaque identifying toothpaste	A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol

Primary Outcome Measures

Name	Time	Method
Change in Hs-CRP Serum Level	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.
Change in Oral Plaque	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.

Secondary Outcome Measures

Name	Time	Method
Change in Oral Plaque - PSS Analysis	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).
Change in Inflammation - PSS Analysis	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