Trial Outcomes & Findings for A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing (NCT NCT00855933)
NCT ID: NCT00855933
Last Updated: 2013-02-08
Results Overview
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.
COMPLETED
PHASE4
60 participants
4 weeks
2013-02-08
Participant Flow
Participant milestones
| Measure |
Brushing Only
Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
|
Brushing + Flossing
Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Brushing Only
Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
|
Brushing + Flossing
Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Baseline characteristics by cohort
| Measure |
Brushing Only
n=30 Participants
Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
|
Brushing + Flossing
n=30 Participants
Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
29.5 years
STANDARD_DEVIATION 10.08 • n=99 Participants
|
27.8 years
STANDARD_DEVIATION 9.41 • n=107 Participants
|
28.7 years
STANDARD_DEVIATION 9.71 • n=206 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
Guatemala
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Whole Mouth Average Lobene Modified Gingival Index
|
2.41 Units on a scale
STANDARD_DEVIATION 0.28 • n=99 Participants
|
2.38 Units on a scale
STANDARD_DEVIATION 0.27 • n=107 Participants
|
2.40 Units on a scale
STANDARD_DEVIATION 0.27 • n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeksA 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.
Outcome measures
| Measure |
Brushing Only
n=30 Participants
Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
|
Brushing + Flossing
n=30 Participants
Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
|
|---|---|---|
|
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 units on a scale
Standard Error 0.047 • Interval -0.03 to 0.24
|
1.73 units on a scale
Standard Error 0.047 • Interval -0.03 to 0.24
|
Adverse Events
Brushing Only
Brushing + Flossing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60