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Investigate Oral Bacteria in Adult Population

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: NCT00762177
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : February 14, 2011
Last Update Posted : March 23, 2011
Sponsor:
Information provided by:
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Oral Bacteria
Interventions Drug: Fluoride
Drug: Fluoride, Triclosan
Drug: Stannous Fluoride
Enrollment 24
Recruitment Details subjects were recruited by the PI at the clinical site
Pre-assignment Details Subjects were screened for medical and oral health criteria and then entered a 1 week washout.
Arm/Group Title Placebo 1st, Active Comparator 2nd and Experimental 3rd Active Comparator 1st, Experimental 2nd, Placebo 3rd Experimental 1st, Placebo 2nd, Active Comparator 3rd
Hide Arm/Group Description Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention. Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention. Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention.
Period Title: 1st Treatment Period
Started 8 8 8
Completed 8 8 8
Not Completed 0 0 0
Period Title: Washout After 1st Treatment
Started 8 8 8
Completed 8 8 8
Not Completed 0 0 0
Period Title: 2nd Treatment Period
Started 8 8 8
Completed 8 8 8
Not Completed 0 0 0
Period Title: Washout After 2nd Treatment
Started 8 8 8
Completed 8 8 8
Not Completed 0 0 0
Period Title: 3rd Treatment Period
Started 8 8 8
Completed 8 8 8
Not Completed 0 0 0
Arm/Group Title Placebo 1st, Active Comparator 2nd and Experimental 3rd Active Comparator 1st, Experimental 2nd, Placebo 3rd Experimental 1st, Placebo 2nd, Active Comparator 3rd Total
Hide Arm/Group Description Participants brushed their teeth with the placebo control (fluoride toothpaste only)during the first intervention then brushed with active comparator(fluoride/triclosan/copolymer toothpaste) during the second intervention and experimental product (stannous fluoride toothpaste) during as the last intervention. Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste)during the first intervention, then brushed with experimental product (stannous fluoride toothpaste) during the second intervention, and brushed with the placebo control (fluoride toothpaste only)as the last intervention. Participants brushed their teeth with the experimental product (stannous fluoride toothpaste) during the first intervention, then brushed with the placebo control (fluoride toothpaste only) during the second intervention and Active Comparator(fluoride/triclosan/copolymer toothpaste)as the last intervention. Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
8
 100.0%
8
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 24 participants
39.87  (10.72) 40.12  (9.38) 36.5  (7.46) 38.83  (9.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 24 participants
Female
7
  87.5%
5
  62.5%
4
  50.0%
16
  66.7%
Male
1
  12.5%
3
  37.5%
4
  50.0%
8
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 8 participants 24 participants
8 8 8 24
1.Primary Outcome
Title Antimicrobial Species in Plaque(Actinomyces)
Hide Description After 14 days of study product use, dental plaque was scraped from the subject's teeth. The plaque was placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Toothpaste Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
0.023  (0.0478) 0.3881  (0.322) 0.0538  (0.0247)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Toothpaste, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Antimicrobial Species in Saliva(Actinomyces)
Hide Description Saliva was collected, after 14 days of product use, by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only)
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
0.016  (0.0236) 0.3209  (0.0301) 0.1116  (0.0272)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Antimicrobial Species on the Tongue(Actinomycetes)
Hide Description After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.0132  (0.0229) 0.2612  (0.0402) -0.0536  (0.0262)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Primary Outcome
Title Antimicrobial Species on the Cheek(Actinomyces)
Hide Description After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
0.0099  (0.027) 0.2949  (0.0327) -0.1875  (0.0354)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Primary Outcome
Title Antimicrobial Species in Plaque(Total Anaerobic)
Hide Description After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.0629  (0.0475) 0.312  (0.0404) 0.0762  (0.0547)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Primary Outcome
Title Antimicrobial Species in Saliva(Total Anaerobic)
Hide Description After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.0247  (0.0266) 0.1505  (0.0298) 0.05  (0.0331)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Primary Outcome
Title Antimicrobial Species in Tongue(Total Anaerobic)
Hide Description After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.0445  (0.0508) 0.2691  (0.0403) 0.0926  (0.0334)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Primary Outcome
Title Antimicrobial Species on the Cheek(Total Anaerobic)
Hide Description After 14 day of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.0551  (0.0259) 0.2009  (0.038) -0.0531  (0.0346)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments the tongue will be scrapped 5 times with the edge of a tongue depressor. The depressor is vortex in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Primary Outcome
Title Antimicrobial Species in Plaque(Fusobacteria)
Hide Description After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.2973  (0.0503) 0.2703  (0.0431) -0.0095  (0.038)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Primary Outcome
Title Antimicrobial Species in Saliva(Fusobacteria)
Hide Description After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.0096  (0.0265) 0.194  (0.0356) 0.0539  (0.0311)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
11.Primary Outcome
Title Antimicrobial Species in Tongue(Fusobacteria)
Hide Description After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.0742  (0.0416) 0.377  (0.0495) 0.1668  (0.048)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
12.Primary Outcome
Title Antimicrobial Species on the Cheek(Fusobacteria)
Hide Description After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.0319  (0.0458) 0.1887  (0.0251) 0.111  (0.0265)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
13.Primary Outcome
Title Antimicrobial Species in Plaque(Oral Streptococci)
Hide Description After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.0848  (0.0417) 0.2593  (0.043) -0.0096  (0.0358)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
14.Primary Outcome
Title Antimicrobial Species in Saliva(Oral Streptococci)
Hide Description After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.0436  (0.0307) 0.1445  (0.0305) 0.087  (0.026)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
15.Primary Outcome
Title Antimicrobial Species in Tongue(Oral Streptococci)
Hide Description After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.1284  (0.0537) 0.2233  (0.0355) 0.0525  (0.0358)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
16.Primary Outcome
Title Antimicrobial Species on the Cheek(Oral Streptococci)
Hide Description After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
0.0126  (0.0326) 0.2088  (0.0388) -0.0251  (0.0309)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
17.Primary Outcome
Title Antimicrobial Species in Plaque(Sulfur Bacteria)
Hide Description After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
0.0174  (0.0625) 0.3083  (0.0424) -0.0416  (0.057)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
18.Primary Outcome
Title Antimicrobial Species in Saliva(Sulfur Bacteria)
Hide Description After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.1213  (0.0494) 0.1556  (0.0375) -0.603  (0.0315)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
19.Primary Outcome
Title Antimicrobial Species in Tongue(Sulfur Bacteria)
Hide Description After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.083  (0.0564) 0.2065  (0.0474) -0.0248  (0.0511)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
20.Primary Outcome
Title Antimicrobial Species on the Cheek(Sulfur Bacteria)
Hide Description After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.1788  (0.0362) 0.2036  (0.0581) -0.0815  (0.0373)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
21.Primary Outcome
Title Antimicrobial Species in Plaque(Veillonella)
Hide Description After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
0.0007  (0.0478) 0.3658  (0.0322) 0.0316  (0.0247)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
22.Primary Outcome
Title Antimicrobial Species in Saliva(Veillonella)
Hide Description After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on veillonella Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
0.0167  (0.0213) 0.3062  (0.0305) 0.0901  (0.0261)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
23.Primary Outcome
Title Antimicrobial Species in Tongue(Veillonella)
Hide Description After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.002  (0.0229) 0.2724  (0.0402) -0.0424  (0.0262)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
24.Primary Outcome
Title Antimicrobial Species on the Cheek(Veillonella)
Hide Description After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active Comparator Experimental
Hide Arm/Group Description:
Participants brushed their teeth with the placebo control (fluoride toothpaste only).
Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Overall Number of Participants Analyzed 24 24 24
Log Mean (Standard Error)
Unit of Measure: log CFU (Colony forming units)
-0.0732  (0.0351) 0.2579  (0.0426) -0.0676  (0.0294)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active Comparator, Experimental
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo - Fluoride Control Active Comparator Experimental
Hide Arm/Group Description Fluoride only toothpaste (Crest Anti-Cavity) Active Comparator toothpaste containing fluoride/triclosan/copolymer (Total) Experimental test product (stannous fluoride toothpaste)
All-Cause Mortality
Placebo - Fluoride Control Active Comparator Experimental
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo - Fluoride Control Active Comparator Experimental
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo - Fluoride Control Active Comparator Experimental
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%)   0/24 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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 De Vizio
Organization: Colgate Palmolive Co.
Phone: 732-878-7901
EMail: William_Devizio@colpal.com
Layout table for additonal information
Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00762177     History of Changes
Other Study ID Numbers: CRO-0108-BACT-PS-NJ
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: December 14, 2010
Results First Posted: February 14, 2011
Last Update Posted: March 23, 2011