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Product Development Background
Blinded Clinical Evaluation
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Study
Abstract
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Study Journal Publication
Curvex Development
Journal Article
Inquiries
Product
Development Background
Introduction
Curvex and its derivatives were developed to offer
innovative toothbrushes with bristle arrays that would not
only geometrically fit the most difficult-to-clean areas of
the mouth, but
would also utilize the softest filaments in the accepted
range of “soft” toothbrushes, while maintaining plaque removal
efficacy. Within this category, 0.007 inches diameter
bristle filaments are the most commonly used, but they
can be as large as 0.008 inches, (also the start of the
“medium range”) or as small as 0.006 inches (typically labeled Extra
Soft.)
From the outset of the
development effort, three main considerations were
recognized: (1) the softer the bristle, the greater the risk
that bristle deformation would occur from brushing in the
customary to-and-fro motion; (2) a softer bristle must
achieve an adequate level of plaque removal; and (3) if a
softer bristle could be successfully integrated into the
brushhead design, there should be benefits to the gingival
health of the user. The Curvex was the result of these
efforts.
Concept & Theoretical
Research
A key concept underlying the
development of Curvex was that the brushhead would
incorporate a tapering bristle array at each end of a larger
planar mid-section bristle grouping. While that central
segment would function to clean the most easily-reached
areas (e.g. facial surfaces of teeth), the tapering ends
would result in an innovative geometric fit that more
closely approximates the lingual anterior curve of the upper
and lower arches. In addition, when brushing in the
usual longitudinal to-and-fro motion, the end bristle
groupings could support the larger mid-section and thus
potentially reduce bristle splaying. This would permit use
of the softer 0.006 inch diameter
filament without reducing plaque removal efficacy.
To complement this unique
bristle array, a convex head was devised. By curving away
from the roof of the mouth, this not only allowed the
toothbrush to reach further back (when brushing the lingual
of upper molars), but also enabled the end bristle groups to
easily gain contact behind any terminal molar. This
configuration also meant that the toothbrush could avoid
hitting the mandible when reaching the lingual surfaces of
lower molars.
As a third primary design
feature, the neck and handle of the toothbrush were
reverse-curved -- unlike most conventional toothbrushes --
to allow further reach without hitting the tips of the upper
and lower anterior teeth.
Initial Testing
Dr. Harada developed initial
prototypes of his envisioned product by modifying
commercially-available toothbrushes to his specifications
and design. Over a six-month period, he provided samples to
a limited number of dental professionals for evaluation. With their very encouraging feedback, he was determined to
advance the product development effort.
Initial Commercialization
After further trials to
determine optimum dimensions for strength, design,
ergonomics and commercial engineering, design engineers were
recruited to construct computer assisted design (CAD)
drawings with which to create a mould. A pilot run of
toothbrushes was made and distributed to selected dental
professionals. The positive response prompted
investment in increased production capactity.
FDA
The FDA was consulted and their
registration requirements were met. In addition, US
patents were awarded to both the Curvex and Curvex II.
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Blinded Clinical
Evaluation
In 2005, a single-blind
crossover study was conducted to compare plaque removal
using Curvex against the Oral-B 40 Indicator, widely
recognized as the best-selling toothbrush in the world. Led
by Dr. Lisa Harpenau
at the University of the Pacific Arthur A. Dugoni School of
Dentistry, this five-week study demonstrated
that while the Curvex toothbrush has a 25% softer filament
(0.006 inches vs. 0.008 inches), it is as effective as the Oral-B in
plaque removal.
For further information on the study and its conclusions,
click on the links below:
Download the Clinical Study Abstract
Download the Publication in
the
Journal of
Clinical Dentistry
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Journal Article
Dr. Harada was asked by the editors of the Journal of
the American College of Dentists to write the developmental
narrative of the Curvex toothbrush for inclusion in the
Spring 2006 edition. The article describes
how Dr. Harada conceived and developed the Curvex toothbrush
product line to have the softest bristles consistent with
effective plaque removal.
Download the journal
article from the
Journal of the American
College of Dentists
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Inquiries
Dr. Harada welcomes any inquiries.
He can be reached at:
Ergonomic Dental Technologies, Inc.
500 Sansome Street, Suite
604
San Francisco, CA
94111-3211
Email:
Stephen.Harada@edt-curvex.com
Phone:
(800) 563-6788 or
(415) 781-1976
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