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| Name | Class |
|---|---|
| Sunstar, Inc. | INDUSTRY |
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In this three-month interventional clinical trial for the treatment of gingivitis the investigators will assess the use of an oscillating-rotating powered toothbrush in comparison to the use of a manual toothbrush over 12-weeks in the absence of interproximal hygiene.
In this single-masked, parallel-armed, interventional clinical trial for treatment of gingivitis the investigators will assess the use of an oscillating-rotating powered toothbrush in comparison to the use of a manual toothbrush over 12-weeks in the absence of interproximal hygiene. The primary outcome variable is the change from baseline in the Modified Gingival Index at 2, 4 and 12-weeks from Baseline. Secondary outcome variables include change from baseline in bleeding on probing as well as change from baseline in the Turesky Modification of the Quigley-Hein Plaque index measuring overnight plaque formation. There will also be an assessment of single use efficacy in reduction of overnight plaque levels at the baseline visit t
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Powered toothbrush intervention | Experimental | Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study. |
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| Manual toothbrush | No Intervention | Subjects will be provided a manual toothbrush as the control group and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oscillating rotating power toothbrush | Device | a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Gingivitis | Baseline and 12 weeks post-baseline measures. Proportion of bleeding sites per patient was used as Full mouth BOP Score. The score for each site was either 1 for bleeding and 0 for no bleeding. Following is the full description of each outcome measure reported in the protocol. The Modified Gingival Index3 (MGI) will be measured on six sites - mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual - of all teeth using a 0-4 scale. Lower score no inflamation and higher severe inflammation. Dental plaque will be evaluated using the Lobene modification4 of the Turesky modification of the Quigley-Hein Plaque Index (PI)5. The score 0 to 5. Lower score means no plaque and higher score increasing plaque.Full-mouth Probing Pocket Depth (PPD) will be measured on the six locations of each tooth (mesial-buccal, buccal, distal-buccal, mesial-lingual, lingual, distal-lingual) using a periodontal probe. | 12 weeks post-baseline |
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Inclusion Criteria:
A subject who meets all the following criteria will be eligible to enroll in this study.
Exclusion Criteria:
Any subject meeting one of the following criteria will not be included in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marquette University School of Dentistry | Milwaukee | Wisconsin | 53233 | United States |
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Medically healthy subjects between 18 and 65 years of age were recruited by posting flyers around the Milwaukee area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Powered Toothbrush Intervention | Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written and professional oral instructions on its proper use at baseline 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study. Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene |
| FG001 | Manual Toothbrush | Subjects will be provided a manual toothbrush as the control group and given written and professional oral instructions on its proper use at baseline, 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Proportion of total number sites per patient. The score per gingival site is either 0 or 1 with 1 being bleeding after probing and 0 being no bleeding after probing. Since the unit of BOP measure is the patient and we made the measurement 4 times and each time we calculated full mouth score.
| ID | Title | Description |
|---|---|---|
| BG000 | Powered Toothbrush Intervention | Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study. Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene |
| 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 | Change in Gingivitis | Baseline and 12 weeks post-baseline measures. Proportion of bleeding sites per patient was used as Full mouth BOP Score. The score for each site was either 1 for bleeding and 0 for no bleeding. Following is the full description of each outcome measure reported in the protocol. The Modified Gingival Index3 (MGI) will be measured on six sites - mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual - of all teeth using a 0-4 scale. Lower score no inflamation and higher severe inflammation. Dental plaque will be evaluated using the Lobene modification4 of the Turesky modification of the Quigley-Hein Plaque Index (PI)5. The score 0 to 5. Lower score means no plaque and higher score increasing plaque.Full-mouth Probing Pocket Depth (PPD) will be measured on the six locations of each tooth (mesial-buccal, buccal, distal-buccal, mesial-lingual, lingual, distal-lingual) using a periodontal probe. | The analysis was on the number sites per patients. For BOP the score was for proportion of the bleeding sites. Similarly for MGI the score was full mouth average. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks post-baseline |
12 Weeks
Pain
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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 | Powered Toothbrush Intervention | The patients were given power toothbrush with instructions to use |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Dean | Marquette Univeristy | 4142885944 | andrew.dentino@marquette.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 14, 2018 | Sep 9, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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3 month home use parallel-arm design to assess the efficacy of powered toothbrush use in the treatment of gingivitis in a moderate sized population, n=70.
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examiners will be unaware of which toothbrush has been assigned to each subject
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| BG001 | Manual Toothbrush | Subjects will be provided a manual toothbrush as the control group and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study. |
| BG002 | Total | Total of all reporting groups |
| Bleeding Sites |
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| Years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | No | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
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| Bleeding on probing | Mean | Standard Deviation | Average Bleeding Score | Participants |
|
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Powered Toothbrush Intervention | Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written and professional oral instructions on its proper use at baseline 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study. Oscillating rotating power toothbrush: a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene |
| OG001 | Manual Toothbrush | Subjects will be provided a manual toothbrush as the control group and given written and professional oral instructions on its proper use at baseline, 2 and 4 weeks. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study. |
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|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Manual Toothbrush | The patients were given power manual toothbrush with instructions to use | 0 | 24 | 0 | 24 | 0 | 24 |
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| D009057 |
| Stomatognathic Diseases |