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 60 healthy adults with pre-existing gingivitis.
Interventions
DEVICEGlide dental floss
Glide waxed dental floss
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group | 30 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group | 30 days | 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). |
Countries
Guatemala
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brushing Only Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice | 30 |
| Brushing + Flossing Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Brushing Only | Brushing + Flossing | Total |
|---|---|---|---|
| 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 | 30 Participants | 60 Participants |
| Age Continuous | 29.0 years STANDARD_DEVIATION 7.8 | 28.2 years STANDARD_DEVIATION 8.5 | 28.6 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment Guatemala | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
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
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
Time frame: 30 days
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brushing Only | Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group | 2.11 units on a scale | Standard Error 0.05 |
| Brushing + Flossing | Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group | 1.87 units on a scale | Standard Error 0.05 |
p-value: 0.001ANCOVA
Secondary
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).
Time frame: 30 days
Population: per protocol
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Brushing Only | Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group | 2.06 units on a scale | Standard Error 0.05 |
| Brushing + Flossing | Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group | 1.86 units on a scale | Standard Error 0.05 |
p-value: 0.004ANCOVA