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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014