Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brushing Only | No Intervention | Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice | |
| Brushing + Flossing | Experimental | Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glide dental floss | Device | Glide waxed dental floss |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
In order to be included in the study, each subject must:
Exclusion Criteria:
Subjects are excluded from study participation where there is evidence of:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jon Witt, PhD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiologio Oral Y Maxilofacial | Guatemala City | Zone 9 | Guatemala |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Brushing Only | Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice |
| FG001 | Brushing + Flossing | Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brushing Only | Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice |
| BG001 | Brushing + Flossing | Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | per protocol | Posted | Mean | Standard Error | units on a scale | 30 days |
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brushing Only | Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly Eynon | Procter and Gamble | 513-622-2920 | eynon.ha@pg.com |
Not provided
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss |
|
|
|
| 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). | per protocol | Posted | Least Squares Mean | Standard Error | units on a scale | 30 days |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Brushing + Flossing | Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss | 0 | 30 | 0 | 30 |
Not provided
| D009057 |
| Stomatognathic Diseases |