Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

This study has been completed.

Sponsor:

Information provided by:

Colgate Palmolive

ClinicalTrials.gov Identifier:

NCT00966953

First received: September 26, 2008

Last updated: September 14, 2009

Last verified: September 2009

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: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Gingival Diseases
Interventions:	Drug: Fluoride Drug: Triclosan/Fluoride toothpaste Other: antibacterial plant extract

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
The dental clinic staff recruited for this study.

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 Control, Magnolol,Total/Whitening,Honokiol	1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
Total/Whitening, Honokiol, Fluoride Control, Magnolol	1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
Honokiol, Fluoride Control, Magnolol, Total/Whitening	1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
Magnolol, Total/Whitening, Honokiol, Fluoride Control	1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control

Participant Flow for 7 periods

Period 1: 1st Intervention

	Fluoride Control, Magnolol,Total/Whitening,Honokiol	Total/Whitening, Honokiol, Fluoride Control, Magnolol	Honokiol, Fluoride Control, Magnolol, Total/Whitening	Magnolol, Total/Whitening, Honokiol, Fluoride Control
STARTED	6	6	6	7
COMPLETED	6	6	6	7
NOT COMPLETED	0	0	0	0

Period 2: 1 Week Washout After 1st Intervention

	Fluoride Control, Magnolol,Total/Whitening,Honokiol	Total/Whitening, Honokiol, Fluoride Control, Magnolol	Honokiol, Fluoride Control, Magnolol, Total/Whitening	Magnolol, Total/Whitening, Honokiol, Fluoride Control
STARTED	6	6	6	7
COMPLETED	6	6	6	7
NOT COMPLETED	0	0	0	0

Period 3: 2nd Intervention

	Fluoride Control, Magnolol,Total/Whitening,Honokiol	Total/Whitening, Honokiol, Fluoride Control, Magnolol	Honokiol, Fluoride Control, Magnolol, Total/Whitening	Magnolol, Total/Whitening, Honokiol, Fluoride Control
STARTED	6	6	6	7
COMPLETED	6	6	6	7
NOT COMPLETED	0	0	0	0

Period 4: 1 Week Washout After 2nd Intervention

	Fluoride Control, Magnolol,Total/Whitening,Honokiol	Total/Whitening, Honokiol, Fluoride Control, Magnolol	Honokiol, Fluoride Control, Magnolol, Total/Whitening	Magnolol, Total/Whitening, Honokiol, Fluoride Control
STARTED	6	6	6	7
COMPLETED	6	6	6	7
NOT COMPLETED	0	0	0	0

Period 5: 3rd Intervention Order

	Fluoride Control, Magnolol,Total/Whitening,Honokiol	Total/Whitening, Honokiol, Fluoride Control, Magnolol	Honokiol, Fluoride Control, Magnolol, Total/Whitening	Magnolol, Total/Whitening, Honokiol, Fluoride Control
STARTED	6	6	6	7
COMPLETED	6	6	6	7
NOT COMPLETED	0	0	0	0

Period 6: 1 Week Washout After 3rd Intervention

	Fluoride Control, Magnolol,Total/Whitening,Honokiol	Total/Whitening, Honokiol, Fluoride Control, Magnolol	Honokiol, Fluoride Control, Magnolol, Total/Whitening	Magnolol, Total/Whitening, Honokiol, Fluoride Control
STARTED	6	6	6	7
COMPLETED	6	6	6	7
NOT COMPLETED	0	0	0	0

Period 7: 4th Intervention Order

	Fluoride Control, Magnolol,Total/Whitening,Honokiol	Total/Whitening, Honokiol, Fluoride Control, Magnolol	Honokiol, Fluoride Control, Magnolol, Total/Whitening	Magnolol, Total/Whitening, Honokiol, Fluoride Control
STARTED	6	6	6	7
COMPLETED	6	6	6	7
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Fluoride Control, Magnolol,Total/Whitening,Honokiol	1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
Total/Whitening, Honokiol, Fluoride Control, Magnolol	1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
Honokiol, Fluoride Control, Magnolol, Total/Whitening	1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
Magnolol, Total/Whitening, Honokiol, Fluoride Control	1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
Total	Total of all reporting groups

Baseline Measures

	Fluoride Control, Magnolol,Total/Whitening,Honokiol	Total/Whitening, Honokiol, Fluoride Control, Magnolol	Honokiol, Fluoride Control, Magnolol, Total/Whitening	Magnolol, Total/Whitening, Honokiol, Fluoride Control	Total
Number of Participants [units: participants]	6	6	6	7	25
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	6	6	6	7	25
>=65 years	0	0	0	0	0
Age [units: years] Mean ± Standard Deviation	42 ± 11.8	37.8 ± 11.6	46.4 ± 10.9	44.3 ± 7	42.1 ± 10.5
Gender [units: participants]
Female	2	3	3	7	15
Male	4	3	3	0	10
Region of Enrollment [units: participants]
United States	6	6	6	7	25

Outcome Measures

1. Primary:

Plaque Index [ Time Frame: 8 weeks ]

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Serious Adverse Events

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No Serious Adverse Events Entered.

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:	NCT00966953 History of Changes
Other Study ID Numbers:	ERO-0907-PLA-16-RR
Study First Received:	September 26, 2008
Results First Received:	September 26, 2008
Last Updated:	September 14, 2009
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

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