A Phase 4 interventional study of Experimental Floss in Gingivitis, sponsored by Procter and Gamble. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-08.
Sponsored by Procter and Gamble · Phase 4, Interventional, and Treatment
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.
609 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's enrollment of 60 is close to the median of 63 across 494 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Procter and Gamble is the lead sponsor of 83 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
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Exclusion Criteria:
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.
Device: Experimental Floss
Experimental Glide® floss with cetylpyridinium chloride (\~13% dry weight CPC)
Also known as: Glide®, floss, cetylpyridinium chloride, CPC
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.
Time frame: 4 weeks
| Milestone | Brushing Only | Brushing + Flossing |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 29 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| units on a scale | Brushing Only | Brushing + Flossing |
|---|---|---|
| Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale | 1.84 ± 0.047 | 1.73 ± 0.047 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brushing Only | — | 0/30 (0%) | 0/30 (0%) |
| Brushing + Flossing | — | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Brushing Only | Brushing + Flossing | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 30 | 60 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Brushing Only | Brushing + Flossing | Total |
|---|---|---|---|
| Mean | 29.5 ± 10.08 | 27.8 ± 9.41 | 28.7 ± 9.71 |
| Sex: Female, Male(Participants) | Brushing Only | Brushing + Flossing | Total |
|---|---|---|---|
| Female | 26 | 27 | 53 |
| Male | 4 | 3 | 7 |
| Region of Enrollment(participants) | Brushing Only | Brushing + Flossing | Total |
|---|---|---|---|
| Guatemala | 30 | 30 | 60 |
| Whole Mouth Average Lobene Modified Gingival Index(Units on a scale) | Brushing Only | Brushing + Flossing | Total |
|---|---|---|---|
| Mean | 2.41 ± 0.28 | 2.38 ± 0.27 | 2.40 ± 0.27 |
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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