Gingivitis
Conditions
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.
Interventions
DEVICEExperimental Floss
Experimental Glide® floss with cetylpyridinium chloride (\ 13% dry weight CPC)
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale | 4 weeks | 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. |
Countries
Guatemala, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Brushing Only | Total | Brushing + Flossing |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 60 Participants | 30 Participants |
| Age Continuous | 29.5 years STANDARD_DEVIATION 10.08 | 28.7 years STANDARD_DEVIATION 9.71 | 27.8 years STANDARD_DEVIATION 9.41 |
| Region of Enrollment Guatemala | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 26 Participants | 53 Participants | 27 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 3 Participants |
| Whole Mouth Average Lobene Modified Gingival Index | 2.41 Units on a scale STANDARD_DEVIATION 0.28 | 2.40 Units on a scale STANDARD_DEVIATION 0.27 | 2.38 Units on a scale STANDARD_DEVIATION 0.27 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brushing Only | 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 |
| 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 | 1.73 units on a scale | Standard Error 0.047 |
p-value: 0.12695% CI: [-0.03, 0.24]ANCOVA