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| Name | Class |
|---|---|
| Guang Dong Bixdo Health Technology Co.,Ltd | OTHER |
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The objective of the present randomized controlled trial is to evaluate the safety and efficacy of the use of Bixdo A30 Pro Ultra Compact Water Flosser (also referred to as the "Bixdo A30 Portable Water Flosser Travel Set") in addition to a manual toothbrush on clinical parameters of inflammation and bacterial plaque removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Group | Experimental | Those randomized into the interventional group will be asked to use the Bixdo Ultra Compact Water Flosser twice a day for 8 weeks. |
|
| Control Group | Active Comparator | Those randomized into the control group will be asked to only use the study provided manual toothbrush and toothpaste twice a day for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bixdo Ultra Compact Water Flosser | Device | Use of water flosser, in addition to standard tooth brushing, twice a day for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation Reduction | At each of the three study visits, the examiners will conduct a periodontal clinical exam, following standard of care procedure, to evaluate the levels of inflammation in the gingiva of subjects in both the intervention and control groups. | 8 weeks |
| Bacterial plaque removal | At each of the three study visits, subjects will be given dental plaque erythrosine disclosing agents (Sunstar GUM® RED-COTE®) to assess the level of plaque on the subjects teeth | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mabi Singh | Contact | 6176362408 | dentalresearchadministration@tufts.edu | |
| Ann-Marie Billig | Contact | 6176363931 | dentalresearchadministration@tufts.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mabi Singh | Tufts University School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Recruiting | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30496104 | Background | GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. | |
| 16128839 |
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randomized controlled clinical trial
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| Manual toothbrush | Device | For those in the control group, they will be asked to use only the study-provided manual toothbrush, twice a day for 8 weeks. |
|
| Background |
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