NCT01559987

Dental Plaque Removal Study

A Randomized Parallel Method Development Study Comparing Clinical to Subclinical Effects From Oral Cleaning Modalities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gingivitis
• Gum Disease

Interventions

Type	Name	Description
OTHER	Manual Toothbrush only	ADA (American Dental Association) Reference Manual Toothbrush (MTB)
OTHER	MTB + Waterpik Ultra Water Flosser 'High'	MTB + Waterpik Ultra Water Flosser 'High'
OTHER	MTB + Floss (MTB+Floss)	MTB + Floss (MTB+Floss)

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-03-21
• Last updated: 2018-08-31

Locations

1 site across 1 country: United States