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This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Toothbrush 1 | Active Comparator | Manual Toothbrush used for 1 minute twice a day |
|
| Manual Toothbrush 2 | Active Comparator | Manual Toothbrush used for 2 minutes twice a day |
|
| Manual Toothbrush + Interproximal Cleaning 1 | Experimental | Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day |
|
| Manual Toothbrush + Interproximal Cleaning 2 | Experimental | Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Toothbrush | Device | A standard size manual toothbrush to clean visible tooth surfaces |
|
| Measure | Description | Time Frame |
|---|---|---|
| Residual Protein Concentration | Residual protein concentration of interproximal plaque samples | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Protein Concentration | Residual protein concentration of interproximal plaque samples | 28 days |
| Modified Gingival Index | Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Jenkins | POHC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Park Research Center | Fort Wayne | Indiana | 46825 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Manual Toothbrush 1 | Manual Toothbrush used for 1 minute twice a day. |
| FG001 | Manual Toothbrush 2 | Manual Toothbrush used for 2 minutes twice a day. |
| FG002 | Manual Toothbrush + Interproximal Cleaning 1 | Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day. |
| FG003 | Manual Toothbrush + Interproximal Cleaning 2 | Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Manual Toothbrush 1 | Manual Toothbrush used for 1 minute twice a day. |
| BG001 | Manual Toothbrush 2 | Manual Toothbrush used for 2 minutes twice a day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | 1 subject who discontinued prior to Day 14 is excluded from the Manual Toothbrush 2 group 1 subject who discontinued prior to Day 14 is excluded from Manual Toothbrush + Interproximal Cleaning Device 1 group |
| 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 | Residual Protein Concentration | Residual protein concentration of interproximal plaque samples | Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed. | Posted | Least Squares Mean | 95% Confidence Interval | ug/mL | 14 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 1 | Manual Toothbrush used for 1 minute twice a day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left forearm deep vein thrombosis | Vascular disorders | Systematic Assessment | Assessed by the PI as definitely not related to the investigational product. SAE outcome was recovered/resolved. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Apthous ulcer above tooth #7 on attached gingiva | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Philips Healthcare, Office of Medical and Health Affairs | 425 908-1208 | wendy.jenkins@philips.com |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
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|
| Interproximal Cleaning Device | Device | An electronic device that combines water and air to clean between the teeth |
|
|
| 14 days |
| Modified Gingival Index | Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst) | 28 days |
| Gingival Bleeding Index | Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst) | 14 days |
| Gingival Bleeding Index | Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst) | 28 days |
| Adverse Event |
|
| BG002 | Manual Toothbrush + Interproximal Cleaning 1 | Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day. |
| BG003 | Manual Toothbrush + Interproximal Cleaning 2 | Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 1 subject who discontinued prior to Day 14 is excluded from the Manual Toothbrush 2 group 1 subject who discontinued prior to Day 14 is excluded from Manual Toothbrush + Interproximal Cleaning Device 1 group | Count of Participants | Participants |
|
| OG002 |
| Manual Toothbrush + Interproximal Cleaning 1 |
Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day. |
| OG003 | Manual Toothbrush + Interproximal Cleaning 2 | Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day. |
|
|
| Secondary | Residual Protein Concentration | Residual protein concentration of interproximal plaque samples | Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed. | Posted | Least Squares Mean | 95% Confidence Interval | ug/mL | 28 days |
|
|
|
| Secondary | Modified Gingival Index | Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst) | Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 14 days |
|
|
|
| Secondary | Modified Gingival Index | Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst) | Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 28 days |
|
|
|
| Secondary | Gingival Bleeding Index | Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst) | Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 14 days |
|
|
|
| Secondary | Gingival Bleeding Index | Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst) | Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 28 days |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Manual Toothbrush 2 | Manual Toothbrush used for 2 minutes twice a day. | 0 | 73 | 0 | 73 |
| EG002 | Manual Toothbrush + Interproximal Cleaning 1 | Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day. | 1 | 75 | 0 | 75 |
| EG003 | Manual Toothbrush + Interproximal Cleaning 2 | Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day. | 0 | 11 | 1 | 11 |
|
Philips shall have the final authority to determine whether or not to publish study results.
| D013568 | Pathological Conditions, Signs and Symptoms |