A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

January 7, 2013 updated by: Procter and Gamble
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guatemala
      • Guatemala City, Guatemala
        • Luis R. Archila, DDS
  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Dr. Geza Terézhalmy, DDS , MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • cetylpyridinium chloride
  • Glide®
  • floss
  • CPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Investigators

  • Study Director: Aaron Biesbrock, DMD, PhD, Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 4, 2009

First Posted (Estimate)

March 5, 2009

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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