Trial Outcomes & Findings for Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste (NCT NCT02080273)
NCT ID: NCT02080273
Last Updated: 2019-05-20
Results Overview
Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
COMPLETED
PHASE4
135 participants
baseline
2019-05-20
Participant Flow
recruitment completed by the principal investigator at the clinical site.
None. There is no wash out/pre-trial period for enrolled subjects. All accepted subjects were randomized upon study enrollment.
Participant milestones
| Measure |
Colgate Cavity Protection Toothpaste
Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
|
Colgate Total Toothpaste
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
|
Parodontax
Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.
Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
45
|
|
Overall Study
COMPLETED
|
45
|
45
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste
Baseline characteristics by cohort
| Measure |
Colgate Cavity Protection Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
|
Colgate Total Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
|
Parodontax
n=45 Participants
Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.
Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.6 years
n=39 Participants
|
38.6 years
n=41 Participants
|
38.4 years
n=35 Participants
|
38.48 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
69 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
66 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
45 Participants
n=39 Participants
|
45 Participants
n=41 Participants
|
45 Participants
n=35 Participants
|
135 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Thailand
|
45 participants
n=39 Participants
|
45 participants
n=41 Participants
|
45 participants
n=35 Participants
|
135 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: baselineDental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Outcome measures
| Measure |
Parodontax
n=45 Participants
Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.
Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
|
Colgate Cavity Protection Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
|
Colgate Total Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
|
|---|---|---|---|
|
Dental Plaque Score
|
3.59 units on a scale
Standard Deviation 0.36
|
3.53 units on a scale
Standard Deviation 0.37
|
3.55 units on a scale
Standard Deviation 0.36
|
PRIMARY outcome
Timeframe: 3 weeks post treatment useDental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Outcome measures
| Measure |
Parodontax
n=45 Participants
Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.
Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
|
Colgate Cavity Protection Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
|
Colgate Total Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
|
|---|---|---|---|
|
Dental Plaque Score
|
3.50 units on a scale
Standard Deviation 0.25
|
3.46 units on a scale
Standard Deviation 0.15
|
2.98 units on a scale
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: 3 months post treatment useDental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Outcome measures
| Measure |
Parodontax
n=45 Participants
Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.
Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
|
Colgate Cavity Protection Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
|
Colgate Total Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
|
|---|---|---|---|
|
Dental Plaque Score
|
3.45 units on a scale
Standard Deviation 0.42
|
3.31 units on a scale
Standard Deviation 0.42
|
2.45 units on a scale
Standard Deviation 0.29
|
PRIMARY outcome
Timeframe: 6 months post treatment useDental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Outcome measures
| Measure |
Parodontax
n=45 Participants
Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.
Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
|
Colgate Cavity Protection Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
|
Colgate Total Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
|
|---|---|---|---|
|
Dental Plaque Score
|
3.23 units on a scale
Standard Deviation 0.35
|
3.40 units on a scale
Standard Deviation 0.39
|
1.65 units on a scale
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: baselineGingivitis scale (Loe \& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Outcome measures
| Measure |
Parodontax
n=45 Participants
Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.
Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
|
Colgate Cavity Protection Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
|
Colgate Total Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
|
|---|---|---|---|
|
Gingivitis Scores
|
1.77 units on a scale
Standard Deviation 0.20
|
1.77 units on a scale
Standard Deviation 0.15
|
1.78 units on a scale
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: 3 weeks post treatment useGingivitis scale (Loe \& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Outcome measures
| Measure |
Parodontax
n=45 Participants
Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.
Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
|
Colgate Cavity Protection Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
|
Colgate Total Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
|
|---|---|---|---|
|
Gingivitis Scores
|
1.67 units on a scale
Standard Deviation 0.21
|
1.76 units on a scale
Standard Deviation 0.17
|
1.65 units on a scale
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: 3 months post treatment useGingivitis scale (Loe \& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Outcome measures
| Measure |
Parodontax
n=45 Participants
Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.
Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
|
Colgate Cavity Protection Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
|
Colgate Total Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
|
|---|---|---|---|
|
Gingivitis Scores
|
1.67 units on a scale
Standard Deviation 0.34
|
1.63 units on a scale
Standard Deviation 0.32
|
1.27 units on a scale
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: 6 months post treatment useGingivitis scale (Loe \& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Outcome measures
| Measure |
Parodontax
n=45 Participants
Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.
Parodontax toothpaste: 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
|
Colgate Cavity Protection Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Colgate Cavity Protection toothpaste: 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
|
Colgate Total Toothpaste
n=45 Participants
Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
|
|---|---|---|---|
|
Gingivitis Scores
|
1.47 units on a scale
Standard Deviation 0.30
|
1.57 units on a scale
Standard Deviation 0.28
|
0.95 units on a scale
Standard Deviation 0.26
|
Adverse Events
Colgate Cavity Protection Toothpaste
Colgate Total Toothpaste
Parodontax
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place