Back to resultsA Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Primary Purpose
Gingivitis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Experimental Floss
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis
Eligibility 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.
Sites / Locations
- Dr. Geza Terézhalmy, DDS , MA
- Luis R. Archila, DDS
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control - no flossing
Experimental Floss
Arm Description
Subjects brushed thoroughly for one minute with Crest® Cavity Protection toothpaste and an Oral-B® Indicator soft, manual toothbrush once daily.
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.
Outcomes
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00855933
Brief Title
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Official Title
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control - no flossing
Arm Type
No Intervention
Arm Description
Subjects brushed thoroughly for one minute with Crest® Cavity Protection toothpaste and an Oral-B® Indicator soft, manual toothbrush once daily.
Arm Title
Experimental Floss
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Experimental Floss
Other Intervention Name(s)
Glide®, floss, cetylpyridinium chloride, CPC
Intervention Description
Experimental Glide® floss with cetylpyridinium chloride (~13% dry weight CPC)
Primary Outcome Measure Information:
Title
Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Biesbrock, DMD, PhD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Geza Terézhalmy, DDS , MA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Luis R. Archila, DDS
City
Guatemala City
Country
Guatemala
12. IPD Sharing Statement
Learn more about this trial
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
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