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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:
NCT00855933
First received: March 3, 2009
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00855933     History of Changes
Other Study ID Numbers: 2008110
Study First Received: March 3, 2009
Results First Received: December 3, 2012
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013