Investigate Oral Bacteria in Adult Population

This study has been completed.

Sponsor:

Information provided by:

Colgate Palmolive

ClinicalTrials.gov Identifier:

NCT00762177

First received: September 26, 2008

Last updated: February 22, 2011

Last verified: February 2011

History of Changes

Results First Received: December 14, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Oral Bacteria
Interventions:	Drug: Fluoride Drug: Fluoride, Triclosan Drug: Stannous Fluoride

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
subjects were recruited by the PI at the clinical site

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened for medical and oral health criteria and then entered a 1 week washout.

Reporting Groups

	Description
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.

Participant Flow for 5 periods

Period 1: 1st Treatment Period

	Placebo 1st, Active Comparator 2nd and Experimental 3rd	Active Comparator 1st, Experimental 2nd, Placebo 3rd	Experimental 1st, Placebo 2nd, Active Comparator 3rd
STARTED	8	8	8
COMPLETED	8	8	8
NOT COMPLETED	0	0	0

Period 2: Washout After 1st Treatment

	Placebo 1st, Active Comparator 2nd and Experimental 3rd	Active Comparator 1st, Experimental 2nd, Placebo 3rd	Experimental 1st, Placebo 2nd, Active Comparator 3rd
STARTED	8	8	8
COMPLETED	8	8	8
NOT COMPLETED	0	0	0

Period 3: 2nd Treatment Period

	Placebo 1st, Active Comparator 2nd and Experimental 3rd	Active Comparator 1st, Experimental 2nd, Placebo 3rd	Experimental 1st, Placebo 2nd, Active Comparator 3rd
STARTED	8	8	8
COMPLETED	8	8	8
NOT COMPLETED	0	0	0

Period 4: Washout After 2nd Treatment

	Placebo 1st, Active Comparator 2nd and Experimental 3rd	Active Comparator 1st, Experimental 2nd, Placebo 3rd	Experimental 1st, Placebo 2nd, Active Comparator 3rd
STARTED	8	8	8
COMPLETED	8	8	8
NOT COMPLETED	0	0	0

Period 5: 3rd Treatment Period

	Placebo 1st, Active Comparator 2nd and Experimental 3rd	Active Comparator 1st, Experimental 2nd, Placebo 3rd	Experimental 1st, Placebo 2nd, Active Comparator 3rd
STARTED	8	8	8
COMPLETED	8	8	8
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Placebo 1st, Active Comparator 2nd and Experimental 3rd	Active Comparator 1st, Experimental 2nd, Placebo 3rd	Experimental 1st, Placebo 2nd, Active Comparator 3rd	Total
Number of Participants [units: participants]	8	8	8	24
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	8	8	8	24
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	39.87 ± 10.72	40.12 ± 9.38	36.5 ± 7.46	38.83 ± 9.03
Gender [units: participants]
Female	7	5	4	16
Male	1	3	4	8
Region of Enrollment [units: participants]
United States	8	8	8	24

Outcome Measures

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1. Primary:

Antimicrobial Species in Plaque(Actinomyces) [ Time Frame: 14 days ]

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2. Primary:

Antimicrobial Species in Saliva(Actinomyces) [ Time Frame: 14 days ]

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Measure Type	Primary
Measure Title	Antimicrobial Species in Saliva(Actinomyces)
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Placebo	Participants brushed their teeth with the placebo control (fluoride toothpaste only)
Active Comparator	Participants brushed their teeth with the Active Comparator (fluoride/triclosan/copolymer toothpaste).
Experimental	Participants brushed their teeth with the experimental product (stannous fluoride toothpaste).

Measured Values

	Placebo	Active Comparator	Experimental
Number of Participants Analyzed [units: participants]	24	24	24
Antimicrobial Species in Saliva(Actinomyces) [units: log CFU (Colony forming units)] Log Mean ± Standard Error	0.016 ± 0.0236	0.3209 ± 0.0301	0.1116 ± 0.0272

Statistical Analysis 1 for Antimicrobial Species in Saliva(Actinomyces)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.05

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypothesis states that there is no difference between groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

3. Primary:

Antimicrobial Species on the Tongue(Actinomycetes) [ Time Frame: 14 days ]

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4. Primary:

Antimicrobial Species on the Cheek(Actinomyces) [ Time Frame: 14 days ]

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5. Primary:

Antimicrobial Species in Plaque(Total Anaerobic) [ Time Frame: 14 days ]

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6. Primary:

Antimicrobial Species in Saliva(Total Anaerobic) [ Time Frame: 14 days ]

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7. Primary:

Antimicrobial Species in Tongue(Total Anaerobic) [ Time Frame: 14 days ]

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8. Primary:

Antimicrobial Species on the Cheek(Total Anaerobic) [ Time Frame: 14 days ]

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9. Primary:

Antimicrobial Species in Plaque(Fusobacteria) [ Time Frame: 14 days ]

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10. Primary:

Antimicrobial Species in Saliva(Fusobacteria) [ Time Frame: 14 days ]

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11. Primary:

Antimicrobial Species in Tongue(Fusobacteria) [ Time Frame: 14 days ]

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12. Primary:

Antimicrobial Species on the Cheek(Fusobacteria) [ Time Frame: 14 days ]

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13. Primary:

Antimicrobial Species in Plaque(Oral Streptococci) [ Time Frame: 14 days ]

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14. Primary:

Antimicrobial Species in Saliva(Oral Streptococci) [ Time Frame: 14 days ]

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15. Primary:

Antimicrobial Species in Tongue(Oral Streptococci) [ Time Frame: 14 days ]

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16. Primary:

Antimicrobial Species on the Cheek(Oral Streptococci) [ Time Frame: 14 days ]

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17. Primary:

Antimicrobial Species in Plaque(Sulfur Bacteria) [ Time Frame: 14 days ]

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18. Primary:

Antimicrobial Species in Saliva(Sulfur Bacteria) [ Time Frame: 14 days ]

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19. Primary:

Antimicrobial Species in Tongue(Sulfur Bacteria) [ Time Frame: 14 days ]

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20. Primary:

Antimicrobial Species on the Cheek(Sulfur Bacteria) [ Time Frame: 14 days ]

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21. Primary:

Antimicrobial Species in Plaque(Veillonella) [ Time Frame: 14 days ]

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22. Primary:

Antimicrobial Species in Saliva(Veillonella) [ Time Frame: 14 days ]

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23. Primary:

Antimicrobial Species in Tongue(Veillonella) [ Time Frame: 14 days ]

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24. Primary:

Antimicrobial Species on the Cheek(Veillonella) [ Time Frame: 14 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: William De Vizio
Organization: Colgate Palmolive Co.
phone: 732-878-7901
e-mail: William_Devizio@colpal.com

No publications provided

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
Study First Received:	September 26, 2008
Results First Received:	December 14, 2010
Last Updated:	February 22, 2011
Health Authority:	United States: Food and Drug Administration

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