Trial Outcomes & Findings for Investigate Oral Bacteria in Adult Population (NCT NCT00762177)

NCT ID: NCT00762177

Last Updated: 2011-03-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 24 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2011-03-23

Participant Flow

subjects were recruited by the PI at the clinical site

Subjects were screened for medical and oral health criteria and then entered a 1 week washout.

Participant milestones

Measure	Placebo 1st, Active Comparator 2nd and Experimental 3rd 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.	Active Comparator 1st, Experimental 2nd, Placebo 3rd 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.	Experimental 1st, Placebo 2nd, Active Comparator 3rd 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.
1st Treatment Period STARTED	8	8	8
1st Treatment Period COMPLETED	8	8	8
1st Treatment Period NOT COMPLETED	0	0	0
Washout After 1st Treatment STARTED	8	8	8
Washout After 1st Treatment COMPLETED	8	8	8
Washout After 1st Treatment NOT COMPLETED	0	0	0
2nd Treatment Period STARTED	8	8	8
2nd Treatment Period COMPLETED	8	8	8
2nd Treatment Period NOT COMPLETED	0	0	0
Washout After 2nd Treatment STARTED	8	8	8
Washout After 2nd Treatment COMPLETED	8	8	8
Washout After 2nd Treatment NOT COMPLETED	0	0	0
3rd Treatment Period STARTED	8	8	8
3rd Treatment Period COMPLETED	8	8	8
3rd Treatment Period NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigate Oral Bacteria in Adult Population

Baseline characteristics by cohort

Measure	Placebo 1st, Active Comparator 2nd and Experimental 3rd n=8 Participants 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.	Active Comparator 1st, Experimental 2nd, Placebo 3rd n=8 Participants 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.	Experimental 1st, Placebo 2nd, Active Comparator 3rd n=8 Participants 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 n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	24 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	39.87 years STANDARD_DEVIATION 10.72 • n=5 Participants	40.12 years STANDARD_DEVIATION 9.38 • n=7 Participants	36.5 years STANDARD_DEVIATION 7.46 • n=5 Participants	38.83 years STANDARD_DEVIATION 9.03 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	24 participants n=4 Participants

PRIMARY outcome

Timeframe: 14 days

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

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Plaque(Actinomyces)	0.023 log CFU (Colony forming units) Standard Error 0.0478	0.3881 log CFU (Colony forming units) Standard Error 0.322	0.0538 log CFU (Colony forming units) Standard Error 0.0247

PRIMARY outcome

Timeframe: 14 days

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

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Saliva(Actinomyces)	0.016 log CFU (Colony forming units) Standard Error 0.0236	0.3209 log CFU (Colony forming units) Standard Error 0.0301	0.1116 log CFU (Colony forming units) Standard Error 0.0272

PRIMARY outcome

Timeframe: 14 days

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

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species on the Tongue(Actinomycetes)	-0.0132 log CFU (Colony forming units) Standard Error 0.0229	0.2612 log CFU (Colony forming units) Standard Error 0.0402	-0.0536 log CFU (Colony forming units) Standard Error 0.0262

PRIMARY outcome

Timeframe: 14 days

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

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species on the Cheek(Actinomyces)	0.0099 log CFU (Colony forming units) Standard Error 0.027	0.2949 log CFU (Colony forming units) Standard Error 0.0327	-0.1875 log CFU (Colony forming units) Standard Error 0.0354

PRIMARY outcome

Timeframe: 14 days

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

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Plaque(Total Anaerobic)	-0.0629 log CFU (Colony forming units) Standard Error 0.0475	0.312 log CFU (Colony forming units) Standard Error 0.0404	0.0762 log CFU (Colony forming units) Standard Error 0.0547

PRIMARY outcome

Timeframe: 14 days

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

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Saliva(Total Anaerobic)	-0.0247 log CFU (Colony forming units) Standard Error 0.0266	0.1505 log CFU (Colony forming units) Standard Error 0.0298	0.05 log CFU (Colony forming units) Standard Error 0.0331

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Tongue(Total Anaerobic)	-0.0445 log CFU (Colony forming units) Standard Error 0.0508	0.2691 log CFU (Colony forming units) Standard Error 0.0403	0.0926 log CFU (Colony forming units) Standard Error 0.0334

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species on the Cheek(Total Anaerobic)	-0.0551 log CFU (Colony forming units) Standard Error 0.0259	0.2009 log CFU (Colony forming units) Standard Error 0.038	-0.0531 log CFU (Colony forming units) Standard Error 0.0346

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Plaque(Fusobacteria)	-0.2973 log CFU (Colony forming units) Standard Error 0.0503	0.2703 log CFU (Colony forming units) Standard Error 0.0431	-0.0095 log CFU (Colony forming units) Standard Error 0.038

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Saliva(Fusobacteria)	-0.0096 log CFU (Colony forming units) Standard Error 0.0265	0.194 log CFU (Colony forming units) Standard Error 0.0356	0.0539 log CFU (Colony forming units) Standard Error 0.0311

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Tongue(Fusobacteria)	-0.0742 log CFU (Colony forming units) Standard Error 0.0416	0.377 log CFU (Colony forming units) Standard Error 0.0495	0.1668 log CFU (Colony forming units) Standard Error 0.048

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species on the Cheek(Fusobacteria)	-0.0319 log CFU (Colony forming units) Standard Error 0.0458	0.1887 log CFU (Colony forming units) Standard Error 0.0251	0.111 log CFU (Colony forming units) Standard Error 0.0265

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Plaque(Oral Streptococci)	-0.0848 log CFU (Colony forming units) Standard Error 0.0417	0.2593 log CFU (Colony forming units) Standard Error 0.043	-0.0096 log CFU (Colony forming units) Standard Error 0.0358

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Saliva(Oral Streptococci)	-0.0436 log CFU (Colony forming units) Standard Error 0.0307	0.1445 log CFU (Colony forming units) Standard Error 0.0305	0.087 log CFU (Colony forming units) Standard Error 0.026

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Tongue(Oral Streptococci)	-0.1284 log CFU (Colony forming units) Standard Error 0.0537	0.2233 log CFU (Colony forming units) Standard Error 0.0355	0.0525 log CFU (Colony forming units) Standard Error 0.0358

PRIMARY outcome

Timeframe: 14 days

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

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species on the Cheek(Oral Streptococci)	0.0126 log CFU (Colony forming units) Standard Error 0.0326	0.2088 log CFU (Colony forming units) Standard Error 0.0388	-0.0251 log CFU (Colony forming units) Standard Error 0.0309

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Plaque(Sulfur Bacteria)	0.0174 log CFU (Colony forming units) Standard Error 0.0625	0.3083 log CFU (Colony forming units) Standard Error 0.0424	-0.0416 log CFU (Colony forming units) Standard Error 0.057

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Saliva(Sulfur Bacteria)	-0.1213 log CFU (Colony forming units) Standard Error 0.0494	0.1556 log CFU (Colony forming units) Standard Error 0.0375	-0.603 log CFU (Colony forming units) Standard Error 0.0315

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Tongue(Sulfur Bacteria)	-0.083 log CFU (Colony forming units) Standard Error 0.0564	0.2065 log CFU (Colony forming units) Standard Error 0.0474	-0.0248 log CFU (Colony forming units) Standard Error 0.0511

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species on the Cheek(Sulfur Bacteria)	-0.1788 log CFU (Colony forming units) Standard Error 0.0362	0.2036 log CFU (Colony forming units) Standard Error 0.0581	-0.0815 log CFU (Colony forming units) Standard Error 0.0373

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Plaque(Veillonella)	0.0007 log CFU (Colony forming units) Standard Error 0.0478	0.3658 log CFU (Colony forming units) Standard Error 0.0322	0.0316 log CFU (Colony forming units) Standard Error 0.0247

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Saliva(Veillonella)	0.0167 log CFU (Colony forming units) Standard Error 0.0213	0.3062 log CFU (Colony forming units) Standard Error 0.0305	0.0901 log CFU (Colony forming units) Standard Error 0.0261

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species in Tongue(Veillonella)	-0.002 log CFU (Colony forming units) Standard Error 0.0229	0.2724 log CFU (Colony forming units) Standard Error 0.0402	-0.0424 log CFU (Colony forming units) Standard Error 0.0262

PRIMARY outcome

Timeframe: 14 days

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.

Outcome measures

Measure	Placebo Toothpaste n=24 Participants Participants brushed their teeth with the placebo control (fluoride toothpaste only).	Active Comparator n=24 Participants Participants brushed their teeth with the Active Comparator(fluoride/triclosan/copolymer toothpaste).	Experimental n=24 Participants Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).
Antimicrobial Species on the Cheek(Veillonella)	-0.0732 log CFU (Colony forming units) Standard Error 0.0351	0.2579 log CFU (Colony forming units) Standard Error 0.0426	-0.0676 log CFU (Colony forming units) Standard Error 0.0294

Adverse Events

Placebo - Fluoride Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William De Vizio

Colgate Palmolive Co.

Phone: 732-878-7901

Email: William_Devizio@colpal.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60