Evaluating Commercial Anti-Plaque Products and Oral Rinse

This study has been completed.

Sponsor:

Information provided by:

Colgate Palmolive

ClinicalTrials.gov Identifier:

NCT01014143

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: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Dental Plaque
Interventions:	Drug: Fluoride Drug: Chlorhexidine digluconate Drug: Fluoride, triclosan

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
Recruitment was performed by the 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 Toothpaste First	Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
Total Toothpaste First	triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
Chlorhexidine Oral Rinse First	chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last

Participant Flow for 5 periods

Period 1: First Intervention

	Fluoride Toothpaste First	Total Toothpaste First	Chlorhexidine Oral Rinse First
STARTED	10	9	9
COMPLETED	10	9	9
NOT COMPLETED	0	0	0

Period 2: Washout Period After 1st Intervention

	Fluoride Toothpaste First	Total Toothpaste First	Chlorhexidine Oral Rinse First
STARTED	10	9	9
COMPLETED	10	9	9
NOT COMPLETED	0	0	0

Period 3: Second Intervention

	Fluoride Toothpaste First	Total Toothpaste First	Chlorhexidine Oral Rinse First
STARTED	10	9	9
COMPLETED	8	9	9
NOT COMPLETED	2	0	0
Lost to Follow-up	2	0	0

Period 4: Washout After 2nd Intervention

	Fluoride Toothpaste First	Total Toothpaste First	Chlorhexidine Oral Rinse First
STARTED	8	9	9
COMPLETED	8	9	9
NOT COMPLETED	0	0	0

Period 5: Third Intervention

	Fluoride Toothpaste First	Total Toothpaste First	Chlorhexidine Oral Rinse First
STARTED	8	9	9
COMPLETED	8	9	9
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Fluoride Toothpaste	negative control
Total Toothpaste	triclosan/fluoride toothpaste (positive control toothpaste)
Chlorhexidine Oral Rinse	chlorhexidine mouthrinse (positive control rinse)
Total	Total of all reporting groups

Baseline Measures

	Fluoride Toothpaste	Total Toothpaste	Chlorhexidine Oral Rinse	Total
Number of Participants [units: participants]	10	9	9	28
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	10	9	9	28
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	47.6 ± 15.1	39 ± 9.2	47.2 ± 9.6	44.5 ± 11.7
Gender [units: participants]
Female	7	6	9	22
Male	3	3	0	6
Region of Enrollment [units: participants]
United States	10	9	9	28

Outcome Measures

1. Primary:

Plaque Index [ Time Frame: Four days ]

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Serious Adverse Events

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Time Frame	6 weeks
Additional Description	subjects were examined at each clinic visit for any signs of side effects while using the study products. If any subject developed any potential side effect while using the study products, they called 24 hour contact number to report it and made an appointment with the clinician to have the side effect evaluated.

Reporting Groups

	Description
Fluoride Toothpaste First	Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
Total Toothpaste First	triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
Chlorhexidine Oral Rinse First	chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last

Serious Adverse Events

	Fluoride Toothpaste First	Total Toothpaste First	Chlorhexidine Oral Rinse First
Total, serious adverse events
# participants affected / at risk	0/28 (0.00%)	0/28 (0.00%)	0/28 (0.00%)

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:	NCT01014143 History of Changes
Other Study ID Numbers:	CRO-2007-PLA-15-RR
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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