- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00855933
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Guatemala City, Guatemala
- Luis R. Archila, DDS
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Texas
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San Antonio, Texas, United States, 78229
- Dr. Geza Terézhalmy, DDS , MA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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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.
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Experimental Glide® floss with cetylpyridinium chloride (~13% dry weight CPC)
Other Names:
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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
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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
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Aaron Biesbrock, DMD, PhD, Procter and Gamble
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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