Efficacy of Salivary Bacteria and Post Brushing

This study has been completed.

Sponsor:

Information provided by:

Colgate Palmolive

ClinicalTrials.gov Identifier:

NCT00981825

First received: September 26, 2008

Last updated: June 10, 2011

Last verified: June 2011

History of Changes

Results First Received: September 26, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Salivary Bacteria Levels
Interventions:	Drug: Fluoride Drug: Triclosan/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
At clinical site

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Fluoride 1st , Triclosan/Fluoride 2nd	Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
Triclosan/Fluoride 1st, Fluoride 2nd	Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.

Participant Flow for 3 periods

Period 1: First Intervention

	Fluoride 1st , Triclosan/Fluoride 2nd	Triclosan/Fluoride 1st, Fluoride 2nd
STARTED	11	11
COMPLETED	11	11
NOT COMPLETED	0	0

Period 2: Washout After 1st Intervention

	Fluoride 1st , Triclosan/Fluoride 2nd	Triclosan/Fluoride 1st, Fluoride 2nd
STARTED	11	11
COMPLETED	11	11
NOT COMPLETED	0	0

Period 3: Second Intervention

	Fluoride 1st , Triclosan/Fluoride 2nd	Triclosan/Fluoride 1st, Fluoride 2nd
STARTED	11	11
COMPLETED	11	11
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Fluoride 1st, Triclosan/Fluoride 2nd	Fluoride toothpaste (placebo)
Triclosan/Fluoride 1st, Fluoride 2nd	Triclosan/Fluoride toothpaste (experimental)
Total	Total of all reporting groups

Baseline Measures

	Fluoride 1st, Triclosan/Fluoride 2nd	Triclosan/Fluoride 1st, Fluoride 2nd	Total
Number of Participants [units: participants]	11	11	22
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	11	11	22
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	30.8 ± 6.8	30.5 ± 8.7	30.6 ± 7.6
Gender [units: participants]
Female	7	7	14
Male	4	4	8
Region of Enrollment [units: participants]
India	11	11	22

Outcome Measures

1. Primary:

CFU (Colony Forming Units) [ Time Frame: 4 hours ]

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Measure Type	Primary
Measure Title	CFU (Colony Forming Units)
Measure Description	Total number of salivary bacterial colony forming units (lower number = less colonies present)
Time Frame	4 hours
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
Fluoride Toothpaste (Control)	Fluoride toothpaste (control)
Triclosan/Fluoride Toothpaste	Triclosan/Fluoride toothpaste (experimental)

Measured Values

	Fluoride Toothpaste (Control)	Triclosan/Fluoride Toothpaste
Number of Participants Analyzed [units: participants]	22	22
CFU (Colony Forming Units) [units: number of colony forming units] Mean ± Standard Deviation	7.18 ± 0.61	6.94 ± 0.40

Statistical Analysis 1 for CFU (Colony Forming Units)

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.

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 DeVizio - DMD
Organization: Colgate Palmolive
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:	NCT00981825 History of Changes
Other Study ID Numbers:	ER0-2007-SAL-01-GX
Study First Received:	September 26, 2008
Results First Received:	September 26, 2008
Last Updated:	June 10, 2011
Health Authority:	United States: Food and Drug Administration

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