Investigate Oral Bacteria in Adult Population

• Sponsor: Colgate Palmolive (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00762177
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 3
• Duration (Months): 4
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

To compare the antimicrobial efficacy of three dentifrices on oral bacteria

Condition or Disease	Intervention/Treatment	Phase
Oral Bacteria	Drug: Fluoride; Drug: Fluoride, Triclosan; Drug: Stannous Fluoride	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Investigate Oral Bacteria in Adult Population
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: A -Control fluoride toothpaste	Drug: Fluoride; Brush twice a day for 14 days; Other Names: Crest Anti-Cavity toothpaste
Experimental: B Experimental toothpaste Stannous fluoride toothpaste	Drug: Stannous Fluoride; Brush twice daily for 14 days
Active Comparator: C- positive control fluoride/triclosan/copolymer toothpaste	Drug: Fluoride, Triclosan; Brush twice daily for 14 days; Other Names: Total toothpaste

Outcome Measures

Primary Outcome Measures

1. Antimicrobial Species in Plaque(Actinomyces) [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

2. Antimicrobial Species in Saliva(Actinomyces) [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

3. Antimicrobial Species on the Tongue(Actinomycetes) [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

4. Antimicrobial Species on the Cheek(Actinomyces) [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

5. Antimicrobial Species in Plaque(Total Anaerobic) [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

6. Antimicrobial Species in Saliva(Total Anaerobic) [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

7. Antimicrobial Species in Tongue(Total Anaerobic) [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.

8. Antimicrobial Species on the Cheek(Total Anaerobic) [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.

9. Antimicrobial Species in Plaque(Fusobacteria) [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.

10. Antimicrobial Species in Saliva(Fusobacteria) [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.

11. Antimicrobial Species in Tongue(Fusobacteria) [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.

12. Antimicrobial Species on the Cheek(Fusobacteria) [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.

13. Antimicrobial Species in Plaque(Oral Streptococci) [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.

14. Antimicrobial Species in Saliva(Oral Streptococci) [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.

15. Antimicrobial Species in Tongue(Oral Streptococci) [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.

16. Antimicrobial Species on the Cheek(Oral Streptococci) [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

17. Antimicrobial Species in Plaque(Sulfur Bacteria) [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.

18. Antimicrobial Species in Saliva(Sulfur Bacteria) [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.

19. Antimicrobial Species in Tongue(Sulfur Bacteria) [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.

20. Antimicrobial Species on the Cheek(Sulfur Bacteria) [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.

21. Antimicrobial Species in Plaque(Veillonella) [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.

22. Antimicrobial Species in Saliva(Veillonella) [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.

23. Antimicrobial Species in Tongue(Veillonella) [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.

24. Antimicrobial Species on the Cheek(Veillonella) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Males and females in good general health aged 18 to 70 years.

• A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and sampling schedules.

• A minimum of 20 natural teeth with facial and lingual scorable surfaces.

• Adequate oral hygiene and no signs of oral neglect.

• Good periodontal health. Enrolled subjects will have periodontal pockets no greater than 5 mm.

• Gingival and plaque indices will also be measured during the first visit. Subjects with gingival index greater than or equal to 1.5 (Lobene Index) and plaque index greater than or equal to 1.5 (Turesky modification of Quigley-Hein Index) will be enrolled.

Exclusion Criteria:

• History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients. Previous known allergy to dental materials, particularly to acrylic-like materials used to fabricate the stent device (this is a highly unlikely occurrence).

• Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars

• Difficulty having dental impressions taken such as excessive gagging.

• History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.

• History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.

• Subjects on antibiotic, antiinflammatory or anticoagulant therapy during the month preceding the baseline exam.

• Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations).

• History of active severe periodontal disease with bleeding gums and loose teeth.

• Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).will not be included in the tooth count.

• Fixed or removable orthodontic appliance or removable partial dentures.

• Participation in a dental plaque/gingivitis clinical study involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the past month.

• Self reported pregnancy or lactation.

• History or current use of objects to pierce the lips or tongue.

• Subjects known to be an alcoholic, or a recovering alcoholic.

• History or current use of recreational drugs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oral Biology	Newark	New York	United States	07103-2714

Sponsors and Collaborators

• Colgate Palmolive

Investigators

• Principal Investigator: Daniel Fine, DDS,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00762177
• Other Study ID Numbers: CRO-0108-BACT-PS-NJ
• First Posted: Sep 30, 2008
• Last Update Posted: Mar 23, 2011
• Last Verified: Feb 1, 2011

• Additional relevant MeSH terms: Triclosan; Fluorides; Tin Fluorides

Study Results

Participant Flow

Recruitment Details	subjects were recruited by the PI at the clinical site
Pre-assignment Detail	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
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: 1st Treatment Period
STARTED	8	8	8
COMPLETED	8	8	8
NOT COMPLETED	0	0	0
Period Title: 1st Treatment Period
STARTED	8	8	8
COMPLETED	8	8	8
NOT COMPLETED	0	0	0
Period Title: 1st Treatment Period
STARTED	8	8	8
COMPLETED	8	8	8
NOT COMPLETED	0	0	0
Period Title: 1st Treatment Period
STARTED	8	8	8
COMPLETED	8	8	8
NOT COMPLETED	0	0	0

Baseline Characteristics

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
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 Participants	8	8	8	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	8 100%	8 100%	8 100%	24 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.87 (10.72)	40.12 (9.38)	36.5 (7.46)	38.83 (9.03)
Sex: Female, Male (Count of Participants)
Female	7 87.5%	5 62.5%	4 50%	16 66.7%
Male	1 12.5%	3 37.5%	4 50%	8 33.3%
Region of Enrollment (participants) [Number]
United States	8 100%	8 100%	8 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Antimicrobial Species in Plaque(Actinomyces)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Toothpaste	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	0.023 (0.0478)	0.3881 (0.322)	0.0538 (0.0247)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

2. Primary Outcome

Title	Antimicrobial Species in Saliva(Actinomyces)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	0.016 (0.0236)	0.3209 (0.0301)	0.1116 (0.0272)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

3. Primary Outcome

Title	Antimicrobial Species on the Tongue(Actinomycetes)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.0132 (0.0229)	0.2612 (0.0402)	-0.0536 (0.0262)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

4. Primary Outcome

Title	Antimicrobial Species on the Cheek(Actinomyces)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	0.0099 (0.027)	0.2949 (0.0327)	-0.1875 (0.0354)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

5. Primary Outcome

Title	Antimicrobial Species in Plaque(Total Anaerobic)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.0629 (0.0475)	0.312 (0.0404)	0.0762 (0.0547)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

6. Primary Outcome

Title	Antimicrobial Species in Saliva(Total Anaerobic)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.0247 (0.0266)	0.1505 (0.0298)	0.05 (0.0331)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

7. Primary Outcome

Title	Antimicrobial Species in Tongue(Total Anaerobic)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.0445 (0.0508)	0.2691 (0.0403)	0.0926 (0.0334)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

8. Primary Outcome

Title	Antimicrobial Species on the Cheek(Total Anaerobic)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.0551 (0.0259)	0.2009 (0.038)	-0.0531 (0.0346)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo Toothpaste, 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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

9. Primary Outcome

Title	Antimicrobial Species in Plaque(Fusobacteria)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.2973 (0.0503)	0.2703 (0.0431)	-0.0095 (0.038)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

10. Primary Outcome

Title	Antimicrobial Species in Saliva(Fusobacteria)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.0096 (0.0265)	0.194 (0.0356)	0.0539 (0.0311)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

11. Primary Outcome

Title	Antimicrobial Species in Tongue(Fusobacteria)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.0742 (0.0416)	0.377 (0.0495)	0.1668 (0.048)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

12. Primary Outcome

Title	Antimicrobial Species on the Cheek(Fusobacteria)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.0319 (0.0458)	0.1887 (0.0251)	0.111 (0.0265)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

13. Primary Outcome

Title	Antimicrobial Species in Plaque(Oral Streptococci)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.0848 (0.0417)	0.2593 (0.043)	-0.0096 (0.0358)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

14. Primary Outcome

Title	Antimicrobial Species in Saliva(Oral Streptococci)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.0436 (0.0307)	0.1445 (0.0305)	0.087 (0.026)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

15. Primary Outcome

Title	Antimicrobial Species in Tongue(Oral Streptococci)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.1284 (0.0537)	0.2233 (0.0355)	0.0525 (0.0358)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

16. Primary Outcome

Title	Antimicrobial Species on the Cheek(Oral Streptococci)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	0.0126 (0.0326)	0.2088 (0.0388)	-0.0251 (0.0309)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

17. Primary Outcome

Title	Antimicrobial Species in Plaque(Sulfur Bacteria)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	0.0174 (0.0625)	0.3083 (0.0424)	-0.0416 (0.057)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

18. Primary Outcome

Title	Antimicrobial Species in Saliva(Sulfur Bacteria)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.1213 (0.0494)	0.1556 (0.0375)	-0.603 (0.0315)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

19. Primary Outcome

Title	Antimicrobial Species in Tongue(Sulfur Bacteria)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.083 (0.0564)	0.2065 (0.0474)	-0.0248 (0.0511)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

20. Primary Outcome

Title	Antimicrobial Species on the Cheek(Sulfur Bacteria)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.1788 (0.0362)	0.2036 (0.0581)	-0.0815 (0.0373)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

21. Primary Outcome

Title	Antimicrobial Species in Plaque(Veillonella)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	0.0007 (0.0478)	0.3658 (0.0322)	0.0316 (0.0247)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

22. Primary Outcome

Title	Antimicrobial Species in Saliva(Veillonella)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	0.0167 (0.0213)	0.3062 (0.0305)	0.0901 (0.0261)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

23. Primary Outcome

Title	Antimicrobial Species in Tongue(Veillonella)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.002 (0.0229)	0.2724 (0.0402)	-0.0424 (0.0262)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

24. Primary Outcome

Title	Antimicrobial Species on the Cheek(Veillonella)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Active Comparator	Experimental
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).
Measure Participants	24	24	24
Log Mean (Standard Error) [log CFU (Colony forming units)]	-0.0732 (0.0351)	0.2579 (0.0426)	-0.0676 (0.0294)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	4 months
Arm/Group Title	Placebo - Fluoride Control		Active Comparator		Experimental
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo - Fluoride Control		Active Comparator		Experimental
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Placebo - Fluoride Control		Active Comparator		Experimental
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.