Trial Outcomes & Findings for Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model (NCT NCT01799226)
NCT ID: NCT01799226
Last Updated: 2016-01-13
Results Overview
Silness \& Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Baseline to 35 Days
Results posted on
2016-01-13
Participant Flow
Initially 15 participants were sought for each arm, but when two were withdrawn from the control arm, two more participants were recruited and randomized, one to each arm. So total start on each arm was 16. The Disqualification noted below for one participant was because s/he no longer met inclusion criteria as of day 14.
Participant milestones
| Measure |
Control Arm
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
|
Test Arm
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
Right Stent Side
|
8
|
8
|
|
Overall Study
Left Stent Side
|
8
|
8
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Control Arm
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
|
Test Arm
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Disqualified at Day 14
|
1
|
0
|
Baseline Characteristics
Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model
Baseline characteristics by cohort
| Measure |
Control Arm
n=16 Participants
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
|
Test Arm
n=16 Participants
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
27.07 years
n=5 Participants
|
26.06 years
n=7 Participants
|
26.57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Bleeding on probing ≤ 10%
|
0.065 Percent of sites bleeding on probing
n=5 Participants
|
0.063 Percent of sites bleeding on probing
n=7 Participants
|
0.064 Percent of sites bleeding on probing
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 35 DaysPopulation: Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
Silness \& Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.
Outcome measures
| Measure |
Control Arm
n=14 Participants
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
|
Test Arm
n=16 Participants
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
|
|---|---|---|
|
Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35
Plaque index Baseline
|
0.37 units on a scale
Standard Error 0.06
|
0.44 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35
Plaque index Day 14
|
1.24 units on a scale
Standard Error 0.07
|
1.49 units on a scale
Standard Error 0.08
|
|
Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35
Plaque index Day 21
|
1.84 units on a scale
Standard Error 0.10
|
1.81 units on a scale
Standard Error 0.10
|
|
Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35
Plaque index Day 35
|
0.45 units on a scale
Standard Error 0.06
|
0.57 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline to 35 DaysPopulation: Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
Loe \& Silness 1963 is a score of 0-3 with 0 = Absence of inflammation, 1 = Mild inflammation, slight change in color and texture, 2 = Moderate inflammation, glazing, redness, edema and hypertrophy, 3 = Severe inflammation, redness and hypertrophy, ulceration. This index was used at days 0, 14, 21 and 35.
Outcome measures
| Measure |
Control Arm
n=14 Participants
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
|
Test Arm
n=16 Participants
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
|
|---|---|---|
|
Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35
Gingival index Baseline
|
0.25 units on a scale
Standard Error 0.04
|
0.32 units on a scale
Standard Error 0.03
|
|
Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35
Gingival index Day 14
|
1.33 units on a scale
Standard Error 0.06
|
1.38 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35
Gingival index Day 21
|
1.56 units on a scale
Standard Error 0.07
|
1.52 units on a scale
Standard Error 0.07
|
|
Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35
Gingival index Day 35
|
0.39 units on a scale
Standard Error 0.07
|
0.47 units on a scale
Standard Error 0.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 35 DaysInflammatory biomarker expression will be quantified using a custom human 10-complex protein array that is optimized for sensitivity, specificity, stability, and intraassay coefficient of variation by comparing to single cytokine enzyme-linked immunosorbent assays (Quantibody Custom Array, RayBiotech, Norcross, GA).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 35 DaysSupra- and sub-gingival plaque samples will be gently collected using a sterile curet and a one stroke method from two randomized sites within the stent area. The detection of 40 bacterial species will be evaluated by the checkerboard DNA-DNA hybridization technique originally described by Socransky et al. 1994.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 35 DaysA total of 10 biomarkers will be analyzed based on the results from Lee and colleagues: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, and TIMP-2.
Outcome measures
Outcome data not reported
Adverse Events
Control Arm
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Test Arm
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Arm
n=16 participants at risk
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
|
Test Arm
n=16 participants at risk
Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
|
|---|---|---|
|
General disorders
Aphthous ulcer
|
6.2%
1/16 • Number of events 1 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
18.8%
3/16 • Number of events 3 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
|
General disorders
Tissue slough
|
12.5%
2/16 • Number of events 2 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
0.00%
0/16 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
|
General disorders
TMJ soreness
|
0.00%
0/16 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
6.2%
1/16 • Number of events 1 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
|
General disorders
Tooth decay
|
6.2%
1/16 • Number of events 1 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
0.00%
0/16 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
|
General disorders
Tingling in tongue
|
0.00%
0/16 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
6.2%
1/16 • Number of events 1 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
|
General disorders
Toothbrush trauma
|
0.00%
0/16 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
6.2%
1/16 • Number of events 1 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
|
General disorders
Herpetic lesion
|
0.00%
0/16 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
12.5%
2/16 • Number of events 2 • All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place