Trial Outcomes & Findings for Trial of Toothpaste to Reduce Plaque and Inflammation (NCT NCT02666508)
NCT ID: NCT02666508
Last Updated: 2021-01-14
Results Overview
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.
COMPLETED
NA
61 participants
Baseline to 30 - 60 days post baseline
2021-01-14
Participant Flow
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.
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.
Participant milestones
| Measure |
Plaque Identifying Toothpaste
A 30 day supply of dosed syringes containing a plaque identifying toothpaste. Toothpaste was dosed in 2 ml syringes and subjects were instructed to use half (1ml) in the morning and half (1ml) in the evening.
|
Non-plaque Identifying Toothpaste
A 30 day supply of dosed syringes containing an identical non-plaque identifying toothpaste. Toothpaste was dosed in 2 ml syringes and subjects were instructed to use half (1ml) in the morning and half (1ml) in the evening.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Toothpaste to Reduce Plaque and Inflammation
Baseline characteristics by cohort
| Measure |
Plaque Identifying Toothpaste
n=31 Participants
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.
|
Non-plaque Identifying Toothpaste
n=30 Participants
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.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Digital Plaque Image Analysis (DPIA)
|
1.69 log(Percentage)
STANDARD_DEVIATION 1.21 • n=5 Participants
|
1.06 log(Percentage)
STANDARD_DEVIATION 1.58 • n=7 Participants
|
1.38 log(Percentage)
STANDARD_DEVIATION 1.43 • n=5 Participants
|
|
High-sensitivity C-Reactive Protein (hs-CRP)
|
0.10 log(mg/L)
STANDARD_DEVIATION 1.30 • n=5 Participants
|
0.24 log(mg/L)
STANDARD_DEVIATION 1.17 • n=7 Participants
|
0.17 log(mg/L)
STANDARD_DEVIATION 1.23 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 30 - 60 days post baselinePopulation: Primary analysis group definition was based on the Intent-to-Treat (ITT) principle.
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.
Outcome measures
| Measure |
Plaque Identifying Toothpaste
n=31 Participants
A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol
Plaque identifying toothpaste: Plaque identifying toothpaste with targetol
|
Non-plaque Identifying Toothpaste
n=30 Participants
A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol
Non-plaque identifying toothpaste: Non-plaque identifying toothpaste without targetol
|
|---|---|---|
|
Change in Oral Plaque
|
-1.05 log(percentage)
Interval -1.45 to -0.66
|
-0.03 log(percentage)
Interval -0.43 to 0.38
|
PRIMARY outcome
Timeframe: Baseline to 30 - 60 days post baselinePopulation: Primary analysis group definition was based on the Intent-to-Treat (ITT) principle.
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.
Outcome measures
| Measure |
Plaque Identifying Toothpaste
n=31 Participants
A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol
Plaque identifying toothpaste: Plaque identifying toothpaste with targetol
|
Non-plaque Identifying Toothpaste
n=30 Participants
A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol
Non-plaque identifying toothpaste: Non-plaque identifying toothpaste without targetol
|
|---|---|---|
|
Change in Hs-CRP Serum Level
|
0.04 log(mg/L)
Interval -0.31 to 0.38
|
0.22 log(mg/L)
Interval -0.13 to 0.58
|
SECONDARY outcome
Timeframe: Baseline to 30-60 days postPopulation: Secondary analysis group definition was based on Pre-Specified Subgroup of subjects such that 30 \<= follow-up \<= 60 days
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).
Outcome measures
| Measure |
Plaque Identifying Toothpaste
n=31 Participants
A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol
Plaque identifying toothpaste: Plaque identifying toothpaste with targetol
|
Non-plaque Identifying Toothpaste
n=29 Participants
A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol
Non-plaque identifying toothpaste: Non-plaque identifying toothpaste without targetol
|
|---|---|---|
|
Change in Oral Plaque - PSS Analysis
|
-1.05 log(percentage)
Interval -1.44 to -0.66
|
-0.10 log(percentage)
Interval -0.5 to 0.31
|
SECONDARY outcome
Timeframe: Baseline to 30-60 days postPopulation: 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
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
Outcome measures
| Measure |
Plaque Identifying Toothpaste
n=19 Participants
A 30 day supply of daily syringes containing a plaque identifying toothpaste with targetol
Plaque identifying toothpaste: Plaque identifying toothpaste with targetol
|
Non-plaque Identifying Toothpaste
n=19 Participants
A 30 day supply of daily syringes containing an identical non plaque identifying toothpaste without targetol
Non-plaque identifying toothpaste: Non-plaque identifying toothpaste without targetol
|
|---|---|---|
|
Change in Inflammation - PSS Analysis
|
-0.40 log(mg/L)
Interval -0.75 to -0.04
|
0.14 log(mg/L)
Interval -0.21 to 0.5
|
Adverse Events
Plaque Identifying Toothpaste
Non-plaque Identifying Toothpaste
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kimberly Fasula RDH, MS, MPH
UIC College of Dentistry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place