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
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
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]

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

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


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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: 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