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| Name | Class |
|---|---|
| Philips Oral Healthcare | INDUSTRY |
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The purpose of this research study is to investigate water flow in dental devices and to understand the function of water flow behind oral hygiene improvements. Understanding this mechanism may help with the design of future products.
The overall clinical response (plaque, gingivitis, bleeding) in participants with varying stages of gingival health as well as the causative or indicative hallmarks of selected biological responses underpinning the overt clinical manifestations described above will be evaluated. The chief biological response that will be investigated is how a reduction in the concentration of bacterial lipopolysaccharide endotoxins (LPS) in interproximal plaque may influence improvements in the clinical response (e.g., through mitigation of bleeding) when compared to a change in the plaque biomass within which a large component of the endotoxins reside. The hypothesis is that improvements in clinical bleeding may result more from the removal or reduction of toxic bacterial products that serve as the direct impetus of the inflammatory response rather than from sheer bulk removal of interproximal plaque. From a methods development perspective, this study will also assess the feasibility of measuring endotoxin load from clinical samples. Ultimately it is anticipated that a comprehensive evaluation of clinical benefits conferred by continuous fluid streaming will emerge upon analysis of the relationships between clinical and biological data sets, particularly where causal relationships may exist between both parameters.
The devices used in this study are subject only to Class I (general controls) and considered exempt from the premarket notification procedures and not subject to section 510(k), 515, or 520(m,) of the FDC Act in order to be legally marketed. Thus, the study does not meet the definition of an Applicable Clinical Trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | ADA (American Dental Association) Reference Manual Toothbrush (MTB) |
|
| Test | Other | MTB + Floss |
|
| MTB + Waterpik Ultra Water Flosser High | Experimental | MTB + Waterpik Ultra Water Flosser High |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Toothbrush only | Other | ADA (American Dental Association) Reference Manual Toothbrush (MTB) |
|
| Measure | Description | Time Frame |
|---|---|---|
| residual protein concentration in posterior sites following in-clinic use of MTB (Manual Toothbrush)+Waterpik Ultra Waterflosser 'high', MTB+floss or MTB alone | The primary endpoint of this study is the residual protein concentration in posterior sites following in-clinic use of MTB+Waterpik Ultra Waterflosser 'high', MTB+floss or MTB alone. | Baseline and Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Gingival Index, Gingival Bleeding index, Plaque Index, and clinical attachment level). | To evaluate the impact of a fluid cleaning principle (MTB+Waterpik Waterflosser) relative to MTB+Floss and MTB alone on clinical outcomes: Modified Gingival Index, Gingival Bleeding index, Plaque Index, and clinical attachment level. | Baseline and Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Offenbacher, DDS, PhD, MMSc | UNC School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General and Oral Health Center | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D005882 | Gingival Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| MTB + Waterpik Ultra Water Flosser 'High' | Other | MTB + Waterpik Ultra Water Flosser 'High' |
|
| MTB + Floss (MTB+Floss) | Other | MTB + Floss (MTB+Floss) |
|
| Number of Adverse Events and Intraoral Exams | Safety endpoints based on adverse event reports and intraoral exam (soft tissue evaluation)findings. | Baseline and week 2 |