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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
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Background: Clinical studies have explored the relationship between toothbrushing and the development of recession, but relevant recession data for the multi-directional power toothbrush (PT) are lacking. The aim of this study was to evaluate the effect of brushing with either a multi-directional power toothbrush (PT) or an ADA (American Dental Association) reference manual toothbrush (MT) on pre-existing mid-buccal gingival recession (Pre-GR) over 12 months
Methods: This was a 12-month, prospective, single-blind, parallel-group, randomized controlled clinical study. Healthy participants without periodontitis but with at least 2 teeth showing Pre-GR ≥2mm were randomized to a group either brushing with a MT or a PT. The primary outcome parameter was the change at sites with Pre-GR ≥2mm. All recession measurements were performed by one calibrated examiner at baseline, 6 and 12 months. Secondary outcomes were changes of recession at all buccal sites (with or without pre-GR), changes in the percentage of recession sites demonstrating a change of ≥1mm as well as changes in pocket probing depths.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual toothbrush | Active Comparator | ADA reference manual toothbrush |
|
| Power toothbrush | Experimental | Multi-directional power toothbrush |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothbrushing with manual toothbrush | Device |
| ||
| Toothbrushing with power toothbrush |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Recession at Sites With Preexisting Recessions ≥2mm | 12 months | |
| Bristle Splay Index (BSI) After a Specific Time-of-use | A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T). | 3, 6, 9 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recession at All Buccal Sites | 12 months | |
| Percentage of Recession Sites Demonstrating a Change of ≥1mm | 12 months | |
| Pocket Probing Depths at 12months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Manual Toothbrush | ADA (American Dental Association) reference manual toothbrush Toothbrushing with manual toothbrush |
| FG001 | Power Toothbrush | Multi-directional power toothbrush Toothbrushing with power toothbrush |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Manual Toothbrush | ADA reference manual toothbrush Toothbrushing with manual toothbrush |
| BG001 | Power Toothbrush | Multi-directional power toothbrush Toothbrushing with power toothbrush |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Gingival Recession at Sites With Preexisting Recessions ≥2mm | Posted | Mean | Standard Deviation | mm | 12 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Manual Toothbrush | ADA reference manual toothbrush Toothbrushing with manual toothbrush |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sonja Sälzer | University Kiel | 00494315972810 | saelzer@konspar.uni-kiel.de |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014099 | Toothbrushing |
| ID | Term |
|---|---|
| D009910 | Oral Hygiene |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
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| Device |
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| 12 months |
| Comparison of BSI Between Periods | 0-3, 9-12 months |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Smoker (Yes/Now) | Number | participants |
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| Previous used toothbrush (MT/PT) | Number | participants |
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| Secondary | Recession at All Buccal Sites | Posted | Mean | Standard Deviation | mm | 12 months |
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| Secondary | Percentage of Recession Sites Demonstrating a Change of ≥1mm | Posted | Number | percentage of sites | 12 months |
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| Secondary | Pocket Probing Depths at 12months | Posted | Mean | Standard Deviation | mm | 12 months |
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| Primary | Bristle Splay Index (BSI) After a Specific Time-of-use | A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T). | Posted | Mean | Standard Deviation | percentage of the original bristle field | 3, 6, 9 and 12 months |
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| Secondary | Comparison of BSI Between Periods | Posted | Mean | Standard Deviation | percentage of the original bristle field | 0-3, 9-12 months |
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| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Power Toothbrush | Multi-directional power toothbrush Toothbrushing with power toothbrush | 0 | 55 | 0 | 55 |
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| D055093 |
| Periodontal Atrophy |