A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00964860
First received: August 20, 2009
Last updated: October 2, 2012
Last verified: October 2012
Results First Received: June 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Gingivitis
Intervention: Device: Glide dental floss

  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
No text entered.

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
Brushing Only Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
Brushing + Flossing Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss

Participant Flow:   Overall Study
    Brushing Only     Brushing + Flossing  
STARTED     30     30  
COMPLETED     30     29  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  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
Brushing Only Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
Brushing + Flossing Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
Total Total of all reporting groups

Baseline Measures
    Brushing Only     Brushing + Flossing     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     30     30     60  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  29.0  ± 7.8     28.2  ± 8.5     28.6  ± 8.1  
Gender  
[units: participants]
     
Female     16     16     32  
Male     14     14     28  
Region of Enrollment  
[units: participants]
     
Guatemala     30     30     60  



  Outcome Measures
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1.  Primary:   Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group   [ Time Frame: 30 days ]

2.  Secondary:   Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Holly Eynon
Organization: Procter and Gamble
phone: 513-622-2920
e-mail: eynon.ha@pg.com


No publications provided


Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00964860     History of Changes
Other Study ID Numbers: 2009061
Study First Received: August 20, 2009
Results First Received: June 28, 2012
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board