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It is well accepted that the greatest contributor to the health of the periodontium and dentition is regular and thorough dental plaque removal, typically by means of adequate toothbrushing. Although patients are typically informed about the risks of substandard oral hygiene and the contributing factors in oral/dental disease by dental professionals, research has shown that an undesirably high proportion of adults find thorough toothbrushing with a standard manual toothbrush to achieve a plaque-free state challenging, as evidenced by high worldwide levels of gingivitis and/or periodontitis.
The purpose of this study is to clinically evaluate the plaque removal efficacy of two electric powered toothbrushes after a single use, as well as the effect on plaque accumulation and gingivitis after 14 days and 30 days period. Simultaneously, a comparison against a manual toothbrush will be made.
Study design: randomised, single blinded, parallel.
After the screening procedure and based on inclusion requirements, all subjects will receive oral prophylaxis (T0) to ensure a baseline of 0 Plaque Index (PI) prior to the first appointment (T1). The subjects will be instructed not to use a tooth brush or any mechanical cleaning device until the initial PI and Gingival Indexes (GI) are taken at 24 hours after T0.
The subjects will be randomized into 3 groups, and the will be provided one of the three evaluated toothbrushes, as well as toothpaste. All subjects will be using identical toothpaste and will receive oral hygiene instructions based on the manufacturer's recommendations.
At T1 initial GI and PI will be taken prior to brushing followed by a second PI reading immediately after the first use of the power driven toothbrush.
The subjects will be instructed to brush twice a day for a period of 2 minutes (following the programmed toothbrush timer) and refrain from using dental floss, tooth pick or any mechanical oral hygiene aid for the period of the study.
On the second visit at 14 days (T2) and third visit at 30 days (T3), additional GI and PI readings will be taken and data will be recorded. All measurements and clinical examinations will be performed by a single blinded examiner. Evaluation on teeth will be made on six teeth #3,7,12,19,23 and 28 (mesio-buccal, buccal, disto-buccal and mesio-lingual, lingual, disto-lingual) following the Silness-Loe Index.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Toothbrush | Active Comparator | Patients will be asked to use a manual toothbrush for 30 days |
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| Sonic Toothbrush | Active Comparator | Patients will be asked to use a sonic toothbrush for 30 days |
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| Pulsating Toothbrush | Active Comparator | Patients will be asked to use a pulsating toothbrush for 30 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral B Healthy Clean Manual Toothbrush | Device | Manual Toothbrush |
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| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index | plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3). | Baseline, 1 month |
| Gingival Index | gingival index as evaluated by Silness-Loe Index, Range 0-3: Score 0 = Normal gingiva. Score 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. Score 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing. Score 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding. | Baseline, 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Dentistry | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulsating Toothbrush | Patients were asked to use a pulsating toothbrush for 30 days Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush |
| FG001 | Sonic Toothbrush |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2019 |
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| BURST Sonic Oral Care |
| Device |
Electric sonic toothbrush |
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| Philipps Sonicare DiamondClean 300 Series | Device | Electric pulsating toothbrush |
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Patients were asked to use a sonic toothbrush for 30 days
BURST Sonic Oral Care: Electric sonic toothbrush
| FG002 | Manual Toothbrush | Patients were asked to use a manual toothbrush for 30 days Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulsating Toothbrush | Patients were asked to use a pulsating toothbrush for 30 days Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush |
| BG001 | Sonic Toothbrush | Patients were asked to use a sonic toothbrush for 30 days BURST Sonic Oral Care: Electric sonic toothbrush |
| BG002 | Manual Toothbrush | Patients were asked to use a manual toothbrush for 30 days Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush |
| BG003 | Total | Total of all reporting groups |
| 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Plaque Index | plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 month |
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| Primary | Gingival Index | gingival index as evaluated by Silness-Loe Index, Range 0-3: Score 0 = Normal gingiva. Score 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. Score 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing. Score 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 month |
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30 days
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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 | Patients will be asked to use a manual toothbrush for 30 days Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush | 0 | 28 | 0 | 28 | 0 | 28 |
| EG001 | Sonic Toothbrush | Patients will be asked to use a sonic toothbrush for 30 days BURST Sonic Oral Care: Electric sonic toothbrush | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Pulsating Toothbrush | Patients will be asked to use a pulsating toothbrush for 30 days Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush | 0 | 24 | 0 | 24 | 0 | 24 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Pi Anfruns, DMD | University of California Los Angeles | 310-825-0834 | jpianfruns@dentistry.ucla.edu |
| Dec 6, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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