Inflammation, Plaque
Conditions
Keywords
plaque identifying toothpaste, plaque score, C-reactive protein
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. .
Interventions
OTHERPlaque identifying toothpaste
Plaque identifying toothpaste with targetol
OTHERNon-plaque identifying toothpaste
Non-plaque identifying toothpaste without targetol
Sponsors
Florida Atlantic University
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Sixty-one apparently healthy subjects aged 19-45 were recruited from the University of Illinois at Chicago campus and surrounding Medical District. Recruitment began in August 2015.
Pre-assignment details
This study did not include pre-assignment criteria other than inclusion/exclusion criteria that determined study eligibility. Only 5 of the 66 screened subjects did not meet eligibility for participation. Qualified subjects were then assigned, by computer randomization in Crosspad©, a subject identification number and randomized.
Participants by arm
| Arm | Count |
|---|---|
| Plaque Identifying Toothpaste A 30 day supply of dosed syringes containing a plaque identifying toothpaste
Plaque identifying toothpaste: Plaque identifying toothpaste
Toothpaste is dosed in 2 ml syringes and subjects were instructed to use half (1ml) in the morning and half (1ml) in the evening. | 31 |
| Non-plaque Identifying Toothpaste A 30 day supply of dosed syringes containing an identical non-plaque identifying toothpaste
Non-plaque identifying toothpaste: Non-plaque identifying toothpaste
Toothpaste is dosed in 2 ml syringes and subjects were instructed to use half (1ml) in the morning and half (1ml) in the evening. | 30 |
| Total | 61 |
Baseline characteristics
| Characteristic | Plaque Identifying Toothpaste | Non-plaque Identifying Toothpaste | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 30 Participants | 61 Participants |
| Digital Plaque Image Analysis (DPIA) | 1.69 log(Percentage) STANDARD_DEVIATION 1.21 | 1.06 log(Percentage) STANDARD_DEVIATION 1.58 | 1.38 log(Percentage) STANDARD_DEVIATION 1.43 |
| High-sensitivity C-Reactive Protein (hs-CRP) | 0.10 log(mg/L) STANDARD_DEVIATION 1.3 | 0.24 log(mg/L) STANDARD_DEVIATION 1.17 | 0.17 log(mg/L) STANDARD_DEVIATION 1.23 |
| Race/Ethnicity, Customized Race/Ethnicity African American | 6 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 13 Participants | 10 Participants | 23 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 8 Participants | 8 Participants | 16 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 4 Participants | 7 Participants | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 31 Participants | 30 Participants | 61 Participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
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.
Time frame: Baseline to 30 - 60 days post baseline
Population: Primary analysis group definition was based on the Intent-to-Treat (ITT) principle.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Plaque Identifying Toothpaste | Change in Hs-CRP Serum Level | 0.04 log(mg/L) |
| Non-plaque Identifying Toothpaste | Change in Hs-CRP Serum Level | 0.22 log(mg/L) |
p-value: 0.45995% CI: [-0.69, 0.32]Repeated Measures ANOVA
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.
Time frame: Baseline to 30 - 60 days post baseline
Population: Primary analysis group definition was based on the Intent-to-Treat (ITT) principle.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Plaque Identifying Toothpaste | Change in Oral Plaque | -1.05 log(percentage) |
| Non-plaque Identifying Toothpaste | Change in Oral Plaque | -0.03 log(percentage) |
p-value: 0.00195% CI: [-1.6, -0.44]Repeated Measures ANOVA
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
Time frame: Baseline to 30-60 days post
Population: Secondary analysis group definition for hs-CRP was based on a Pre-Specified Subgroup which had 0.5 \<= baseline hs-CRP \<= 10.0 and 30 \<= follow-up \<= 60 days
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Plaque Identifying Toothpaste | Change in Inflammation - PSS Analysis | -0.40 log(mg/L) |
| Non-plaque Identifying Toothpaste | Change in Inflammation - PSS Analysis | 0.14 log(mg/L) |
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).
Time frame: Baseline to 30-60 days post
Population: Secondary analysis group definition was based on Pre-Specified Subgroup of subjects such that 30 \<= follow-up \<= 60 days
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Plaque Identifying Toothpaste | Change in Oral Plaque - PSS Analysis | -1.05 log(percentage) |
| Non-plaque Identifying Toothpaste | Change in Oral Plaque - PSS Analysis | -0.10 log(percentage) |