Back to resultsA Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Primary Purpose
Gingivitis
Status
Completed
Phase
Phase 3
Locations
Guatemala
Study Type
Interventional
Intervention
Glide dental floss
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis
Eligibility Criteria
Inclusion Criteria:
In order to be included in the study, each subject must:
- be at least 18 years of age;
- be physically able to floss their teeth;
- have a minimum of 18 natural teeth (teeth that are grossly carious, fully crowned, or extensively restored will not be included);
- have refrained from performing oral hygiene the morning of the Baseline visit;
- be in good general health;
- have interproximal MGI (Modified Gingival Index) score of >2.8.
Exclusion Criteria:
Subjects are excluded from study participation where there is evidence of:
- severe periodontal disease;
- discoloration or pigmentation in the gingival tissue;
- meaningful misalignment of front 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
- Radiologio Oral Y Maxilofacial
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Brushing Only
Brushing + Flossing
Arm Description
Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
Outcomes
Primary Outcome Measures
Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group
Gingivitis was scored using the Lobene Modified Gingival Index (a visual examination for inflammation) on all scorable teeth. For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored on a 5-point, categorical scale (0 = absence of inflammation; 4 = severe inflammation) corresponding to Inflammation
Secondary Outcome Measures
Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group
Whole-mouth average MGI scores were calculated separately for each subject and visit by averaging the MGI scores of all gradable sites. Interpoximal average MGI scores were also calculated for each subject and visit by averaging over only interpoximal sites (buccal-mesial, buccal-distal, lingual-mesian, and lingual-distal).
Within each treatment, changes from baseline were analyzed using paired t-test. Between treatments mean comparisons were conducted using analysis of covariance with baseline MGI score as a covariate. All statistical comparisons were two-sided with a 5% significance level.
The average MGI score for a subject can range from 0 (no gingivitis) to 4 (inflammation on all gradable sites).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00964860
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
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 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 60 healthy adults with pre-existing 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 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brushing Only
Arm Type
No Intervention
Arm Description
Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
Arm Title
Brushing + Flossing
Arm Type
Experimental
Arm Description
Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
Intervention Type
Device
Intervention Name(s)
Glide dental floss
Intervention Description
Glide waxed dental floss
Primary Outcome Measure Information:
Title
Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group
Description
Gingivitis was scored using the Lobene Modified Gingival Index (a visual examination for inflammation) on all scorable teeth. For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored on a 5-point, categorical scale (0 = absence of inflammation; 4 = severe inflammation) corresponding to Inflammation
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group
Description
Whole-mouth average MGI scores were calculated separately for each subject and visit by averaging the MGI scores of all gradable sites. Interpoximal average MGI scores were also calculated for each subject and visit by averaging over only interpoximal sites (buccal-mesial, buccal-distal, lingual-mesian, and lingual-distal).
Within each treatment, changes from baseline were analyzed using paired t-test. Between treatments mean comparisons were conducted using analysis of covariance with baseline MGI score as a covariate. All statistical comparisons were two-sided with a 5% significance level.
The average MGI score for a subject can range from 0 (no gingivitis) to 4 (inflammation on all gradable sites).
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
In order to be included in the study, each subject must:
be at least 18 years of age;
be physically able to floss their teeth;
have a minimum of 18 natural teeth (teeth that are grossly carious, fully crowned, or extensively restored will not be included);
have refrained from performing oral hygiene the morning of the Baseline visit;
be in good general health;
have interproximal MGI (Modified Gingival Index) score of >2.8.
Exclusion Criteria:
Subjects are excluded from study participation where there is evidence of:
severe periodontal disease;
discoloration or pigmentation in the gingival tissue;
meaningful misalignment of front 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
Jon Witt, PhD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Radiologio Oral Y Maxilofacial
City
Guatemala City
ZIP/Postal Code
Zone 9
Country
Guatemala
12. IPD Sharing Statement
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A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
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