Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis

This study has been completed.

Sponsor:

Information provided by:

Colgate Palmolive

ClinicalTrials.gov Identifier:

NCT00926328

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: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Gingivitis
Interventions:	Drug: Triclosan, fluoride Drug: 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
Performed by the Research Department School of Dentistry UPR

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Experimental Treatment	triclosan/copolymer/fluoride toothpaste
Placebo Control	sodium fluoride toothpaste

Participant Flow: Overall Study

	Experimental Treatment	Placebo Control
STARTED	60	60
COMPLETED	48	46
NOT COMPLETED	12	14
Lost to Follow-up	12	14

Baseline Characteristics

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Reporting Groups

	Description
Experimental Treatment	triclosan/copolymer/fluoride toothpaste
Placebo Control	sodium fluoride toothpaste
Total	Total of all reporting groups

Baseline Measures

	Experimental Treatment	Placebo Control	Total
Number of Participants [units: participants]	60	60	120
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	58	58	116
>=65 years	2	2	4
Age [units: years] Mean ± Standard Deviation	34.72 ± 8.51	35.95 ± 10.24	35.33 ± 9.39
Gender [units: participants]
Female	45	43	88
Male	15	17	32
Region of Enrollment [units: participants]
Spain	60	60	120

Outcome Measures

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1. Primary:

Gingivitis Index [ Time Frame: 6 months ]

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2. Primary:

Plaque Index [ Time Frame: 6 Months ]

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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
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Results Point of Contact:

Name/Title: William De Vizio, 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:	NCT00926328 History of Changes
Other Study ID Numbers:	CRO-0507-PL-SP-CT-BS
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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