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

History of Changes

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
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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
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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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 ]

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2. Secondary:

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

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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: 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

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