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A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00855933
First Posted: March 5, 2009
Last Update Posted: February 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Procter and Gamble
  Purpose
This is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in healthy adults with mild-to-moderate gingivitis.

Condition Intervention Phase
Gingivitis Device: Experimental Floss Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale [ Time Frame: 4 weeks ]

    A whole-mouth average Lobene Modified Gingival Index was calculated by summing the scores and dividing by the number of sites graded (excludes missing teeth & sites not graded). Whole mouth average can range from 0 (normal) to 4 (severe inflammation).

    For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored using the following scale: 0=Normal (Absence of inflammation, 1=Mild inflammation (slight change in color, little change in texture) of any portion of but not the entire marginal or papillary gingival unit, 2=Mild inflammation criteria as above but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the marginal or papillary gingival unit, 4=Severe inflammation (marked redness, edema and/or hypertrophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit.



Enrollment: 60
Study Start Date: January 2009
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control - no flossing
Subjects brushed thoroughly for one minute with Crest® Cavity Protection toothpaste and an Oral-B® Indicator soft, manual toothbrush once daily.
Experimental: Experimental Floss
Subjects brushed thoroughly for one minute with Crest® Cavity Protection toothpaste and an Oral-B® Indicator soft, manual toothbrush once daily. Subjects flossed once daily with the experimental floss.
Device: Experimental Floss
Experimental Glide® floss with cetylpyridinium chloride (~13% dry weight CPC)
Other Names:
  • Glide®
  • floss
  • cetylpyridinium chloride
  • CPC

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least 18 years of age;
  • physically able to floss his/her teeth;
  • refrained from performing oral hygiene the morning of the Baseline visit;
  • have measurable gingivitis on at least 5 test sites;
  • in good general health.

Exclusion Criteria:

  • severe periodontal disease
  • atypical discoloration or pigmentation in the gingival tissue;
  • meaningful malocclusion of the anterior teeth;
  • fixed facial orthodontic appliances;
  • use of antibiotics within two weeks of the baseline visit and at any time during the study;
  • any diseases or conditions that could be expected to interfere with the subject safely completing the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855933


Locations
United States, Texas
Dr. Geza Terézhalmy, DDS , MA
San Antonio, Texas, United States, 78229
Guatemala
Luis R. Archila, DDS
Guatemala City, Guatemala
Sponsors and Collaborators
Procter and Gamble
Investigators
Study Director: Aaron Biesbrock, DMD, PhD Procter and Gamble
  More Information

Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00855933     History of Changes
Other Study ID Numbers: 2008110
First Submitted: March 3, 2009
First Posted: March 5, 2009
Results First Submitted: December 3, 2012
Results First Posted: February 8, 2013
Last Update Posted: February 8, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Cetylpyridinium
Anti-Infective Agents, Local
Anti-Infective Agents