Effect on Bacterial Glycolytic Acid Formation on Plaque

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Colgate Palmolive

ClinicalTrials.gov Identifier:

NCT00762450

First received: September 26, 2008

Last updated: March 5, 2012

Last verified: March 2012

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: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Dental Plaque
Interventions:	Drug: Triclosan, Fluoride Drug: fluoride Drug: Fluoride, triclosan, amino acid

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 are 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 are screened for medical and oral health criteria and start a 1 week washout period.

Reporting Groups

	Description
Placebo 1st, Active Comparator 2nd and Experimental Last	Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
Active Comparator 1st, Experimental 2nd and Placebo Last	Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.
Experimental 1st, Placebo 2nd and Active Comparator Last	Order of study treatment toothpastes for the enrolled panelist placed in that treatment group. All panelists brushed their teeth with all study treatments, just the order of appearance changed. All panelists rinsed their mouths with a slurry of the assigned toothpaste three times a day for 7 days.

Participant Flow for 5 periods

Period 1: 1st Treatment Period

	Placebo 1st, Active Comparator 2nd and Experimental Last	Active Comparator 1st, Experimental 2nd and Placebo Last	Experimental 1st, Placebo 2nd and Active Comparator Last
STARTED	2	2	2
COMPLETED	2	2	2
NOT COMPLETED	0	0	0

Period 2: Washout After 1st Treatment Period

	Placebo 1st, Active Comparator 2nd and Experimental Last	Active Comparator 1st, Experimental 2nd and Placebo Last	Experimental 1st, Placebo 2nd and Active Comparator Last
STARTED	2	2	2
COMPLETED	2	2	2
NOT COMPLETED	0	0	0

Period 3: 2nd Treatment Period

	Placebo 1st, Active Comparator 2nd and Experimental Last	Active Comparator 1st, Experimental 2nd and Placebo Last	Experimental 1st, Placebo 2nd and Active Comparator Last
STARTED	2	2	2
COMPLETED	2	2	2
NOT COMPLETED	0	0	0

Period 4: Washout After 2nd Treatment Period

	Placebo 1st, Active Comparator 2nd and Experimental Last	Active Comparator 1st, Experimental 2nd and Placebo Last	Experimental 1st, Placebo 2nd and Active Comparator Last
STARTED	2	2	2
COMPLETED	2	2	2
NOT COMPLETED	0	0	0

Period 5: 3rd Treatment Period

	Placebo 1st, Active Comparator 2nd and Experimental Last	Active Comparator 1st, Experimental 2nd and Placebo Last	Experimental 1st, Placebo 2nd and Active Comparator Last
STARTED	2	2	2
COMPLETED	2	2	2
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo First, Positive Control Second and Experimental Last	No text entered.
Positive Control First, Experimental Second and Placebo Last	No text entered.
Experimental First, Placebo Second and Positive Control Last	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Placebo First, Positive Control Second and Experimental Last	Positive Control First, Experimental Second and Placebo Last	Experimental First, Placebo Second and Positive Control Last	Total
Number of Participants [units: participants]	2	2	2	6
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	0	0	0	0
>=65 years	2	2	2	6
Age [units: years] Mean ± Standard Deviation	76.5 ± 3.5	77.5 ± 0.7	73.5 ± 2.1	75.8 ± 2.6
Gender [units: participants]
Female	1	2	1	4
Male	1	0	1	2
Region of Enrollment [units: participants]
Switzerland	2	2	2	6

Outcome Measures

1. Primary:

ph of Dental Plaque After Sucrose Challenge [ Time Frame: 1 week ]

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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:	Colgate Palmolive
ClinicalTrials.gov Identifier:	NCT00762450 History of Changes
Other Study ID Numbers:	CRO-2008-PLA-01-AM
Study First Received:	September 26, 2008
Results First Received:	December 14, 2010
Last Updated:	March 5, 2012
Health Authority:	United States: Food and Drug Administration

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