Clinical Research Study Efficacy of a Prototype Oral Rinse (Quigley)

This study has been completed.

Sponsor:

Information provided by:

Colgate Palmolive

ClinicalTrials.gov Identifier:

NCT01021007

First received: September 26, 2008

Last updated: November 27, 2009

Last verified: October 2009

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:	Dental Plaque
Interventions:	Drug: Iodine Other: water

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
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Reporting Groups

	Description
Negative Control Rinse	Placebo mouthrinse
Iocide Mouthrinse	Experimental mouthrinse

Participant Flow: Overall Study

	Negative Control Rinse	Iocide Mouthrinse
STARTED	36	37
COMPLETED	34	33
NOT COMPLETED	2	4
Lost to Follow-up	1	1
Adverse Event	1	3

Baseline Characteristics

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Reporting Groups

	Description
Negative Control Rinse	Placebo mouthrinse
Iocide Mouthrinse	Experimental mouthrinse
Total	Total of all reporting groups

Baseline Measures

	Negative Control Rinse	Iocide Mouthrinse	Total
Number of Participants [units: participants]	36	37	73
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	36	37	73
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	37.8 ± 8.3	36.6 ± 10.9	37.2 ± 9.6
Gender [units: participants]
Female	29	24	53
Male	7	13	20
Region of Enrollment [units: participants]
United States	36	37	73

Outcome Measures

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1. Primary:

Gingival Index [ Time Frame: 6 weeks ]

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2. Primary:

EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale [ Time Frame: 6 weeks ]

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3. Primary:

Plaque Index (Quigley-Hein Score) [ Time Frame: 6 weeks ]

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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 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:	NCT01021007 History of Changes
Other Study ID Numbers:	CRO-1007-GIN-02-RR
Study First Received:	September 26, 2008
Results First Received:	September 26, 2008
Last Updated:	November 27, 2009
Health Authority:	United States: Food and Drug Administration

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