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Trial record 35 of 43 for:    FLUORIDE ION AND TRICLOSAN

The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02193165
Recruitment Status : Completed
First Posted : July 17, 2014
Results First Posted : February 6, 2015
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Dental Plaque
Gingivitis
Interventions Drug: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
Drug: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
Drug: fluoride toothpaste + fluoride Mouthwash
Enrollment 120
Recruitment Details recruitment at clinical site
Pre-assignment Details There is no wash-out period prior to product randomization and distribution. Each subject was randomized and given a study treatment to follow after successfully completing the study screening procedures.
Arm/Group Title Regimen 1 Regimen 2 Regimen 3 - Control Group
Hide Arm/Group Description

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.

fluoride toothpaste + fluoride Mouthwash

fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Period Title: 4 Week Product Use
Started 40 40 40
Completed 39 [1] 39 [1] 39 [1]
Not Completed 1 1 1
Reason Not Completed
Lost to Follow-up             1             1             1
[1]
1 subject failed to keep appointments and didn't return to clinical site
Period Title: 6 Week Product Use
Started 39 39 39
Completed 39 38 [1] 39
Not Completed 0 1 0
Reason Not Completed
Lost to Follow-up             0             1             0
[1]
1 subject failed to keep appointment time and didn't return to clinical site.
Arm/Group Title Regimen 1 Regimen 2 Regimen 3 - Control Group Total
Hide Arm/Group Description

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.

fluoride toothpaste + fluoride Mouthwash

fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Total of all reporting groups
Overall Number of Baseline Participants 40 40 40 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
  97.5%
38
  95.0%
39
  97.5%
116
  96.7%
>=65 years
1
   2.5%
2
   5.0%
1
   2.5%
4
   3.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 120 participants
Female
17
  42.5%
16
  40.0%
14
  35.0%
47
  39.2%
Male
23
  57.5%
24
  60.0%
26
  65.0%
73
  60.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 120 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
40
 100.0%
40
 100.0%
40
 100.0%
120
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 40 participants 120 participants
40 40 40 120
1.Primary Outcome
Title Dental Plaque Scores
Hide Description 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)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regimen 1 Regimen 2 Regimen 3 - Control Group
Hide Arm/Group Description:

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.

fluoride toothpaste + fluoride Mouthwash

fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.33  (0.52) 3.19  (0.53) 3.31  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regimen 1, Regimen 2, Regimen 3 - Control Group
Comments Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different. Significance will be determined by p<0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.434
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Dental Plaque Scores
Hide Description 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)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regimen 1 Regimen 2 Regimen 3 - Control Group
Hide Arm/Group Description:

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.

fluoride toothpaste + fluoride Mouthwash

fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Overall Number of Participants Analyzed 39 39 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.78  (0.56) 2.79  (0.52) 3.34  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regimen 2, Regimen 3 - Control Group
Comments The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups determined by P<0.05
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Dental Plaque Scores
Hide Description 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)
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regimen 1 Regimen 2 Regimen 3 - Control Group
Hide Arm/Group Description:

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.

fluoride toothpaste + fluoride Mouthwash

fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Overall Number of Participants Analyzed 39 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.42  (0.62) 2.59  (0.58) 3.38  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regimen 1, Regimen 2, Regimen 3 - Control Group
Comments The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups will be determined at P<0.05
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.
Method ANCOVA
Comments [Not Specified]
4.Primary Outcome
Title Gingivitis Scores
Hide Description Gingivitis 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)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regimen 1 Regimen 2 Regimen 3 - Control Group
Hide Arm/Group Description:

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.

fluoride toothpaste + fluoride Mouthwash

fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.40  (0.31) 1.40  (0.32) 1.44  (0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regimen 1, Regimen 2, Regimen 3 - Control Group
Comments Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups. Differences will be noted at P<0.05. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.816
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Primary Outcome
Title Gingivitis Scores
Hide Description Gingivitis 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)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regimen 1 Regimen 2 Regimen 3 - Control Group
Hide Arm/Group Description:

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.

fluoride toothpaste + fluoride Mouthwash

fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Overall Number of Participants Analyzed 39 39 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.19  (0.23) 1.30  (0.27) 1.44  (0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regimen 1, Regimen 2, Regimen 3 - Control Group
Comments The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P<0.05
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.
Method ANCOVA
Comments [Not Specified]
6.Primary Outcome
Title Gingivitis Scores
Hide Description Gingivitis 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)
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regimen 1 Regimen 2 Regimen 3 - Control Group
Hide Arm/Group Description:

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.

fluoride toothpaste + fluoride Mouthwash

fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Overall Number of Participants Analyzed 39 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.03  (0.14) 1.21  (0.24) 1.46  (0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Regimen 1, Regimen 2, Regimen 3 - Control Group
Comments The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P<0.05
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.
Method ANCOVA
Comments [Not Specified]
Time Frame 6 weeks
Adverse Event Reporting Description Duration of study
 
Arm/Group Title Regimen 1 Regimen 2 Regimen 3 - Control Group
Hide Arm/Group Description

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.

fluoride toothpaste + fluoride Mouthwash

fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

All-Cause Mortality
Regimen 1 Regimen 2 Regimen 3 - Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Regimen 1 Regimen 2 Regimen 3 - Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Regimen 1 Regimen 2 Regimen 3 - Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William Devizio
Organization: Colgate Palmolive
Phone: 732-878-7901
EMail: william_devizio@colpal.com
Layout table for additonal information
Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT02193165     History of Changes
Other Study ID Numbers: CRO-2014-07-PG-REG-PR-BS
First Submitted: July 15, 2014
First Posted: July 17, 2014
Results First Submitted: November 14, 2014
Results First Posted: February 6, 2015
Last Update Posted: August 17, 2015