Align Technology Shares Findings From New Clinical Study That Validates the Significant Benefits of the iTero Element 5D Imaging System as an Aid in Detection and Monitoring of Interproximal Caries Lesions (Cavities)
October 27 2021 - 4:00PM
Align Technology Shares Findings From New Clinical Study That
Validates the Significant Benefits of the iTero Element 5D Imaging
System as an Aid in Detection and Monitoring of Interproximal
Caries Lesions (Cavities)
Align Technology, Inc. (“Align”) (Nasdaq: ALGN) a leading global
medical device company that designs, manufactures, and sells the
Invisalign system of clear aligners, iTero intraoral scanners, and
exocad CAD/CAM software for digital orthodontics and restorative
dentistry, today announced the findings of a multi-center clinical
study, “Reflected near-infrared light versus bite-wing radiography
for the detection of proximal caries: a multicenter prospective
clinical study conducted in private practices,” published in the
peer-reviewed Journal of Dentistry (Oct. 24, 2021). The study
validates and further demonstrates the significant benefits of the
iTero Element 5D imaging system as an aid in detection and
monitoring of interproximal caries lesions above the gingiva
without harmful radiation.
The clinical study was designed to compare the
detection of interproximal caries (dental cavities and decay on the
proximal surface(s) of adjacent teeth) by dentists using near
infra-red technology (NIRI) and bitewing radiography (a dental
x-ray designed to show the crowns of the upper and lower posterior
teeth simultaneously). The results demonstrated high accuracy
(p<0.0001) detection of early enamel lesions (88.6%)*** and of
carious lesions involving the dentino-enamel junction (96.9%)***
(the boundary between the enamel and the underlying dentin that
form a tooth).
In addition, the study compared NIRI and
bitewing radiography to visual caries debridement (clinical removal
of tooth decay). When compared against clinical evaluation of
posterior proximal lesions observed during caries debridement, the
NIRI technology of the iTero Element 5D imaging system was 66%**
more sensitive than bitewing x-ray technology and demonstrated
96%** sensitivity for posterior interproximal lesions
detections.
“We are pleased to see the results of these
clinical findings further validate what doctors and their patients
have experienced. The visualization capabilities of the iTero
Element 5D imaging system helps in the early detection of cavities
without x-ray radiation,” said Yuval Shaked, senior vice president
and managing director, iTero scanner and services business, Align
Technology. “This study emphasizes the valuable role that the iTero
5D imaging system with NIRI technology is already providing doctors
and their staff to support their dental assessments of patients and
overall patient oral healthcare and treatment options. When
combined with the ease of use and comfortable experience for a
broad population of patients, the iTero 5D imaging system with NIRI
technology is an essential tool for any doctor’s office.”
As part of the study, the iTero Element 5D
imaging system was used to perform intraoral scans on 100 patients
in five dental clinics across Germany and Canada. The iTero Element
5D imaging system includes NIRI technology that scans the internal
structure of a tooth (enamel and dentin) in real time that aids in
caries detection while simultaneously capturing 3D color images of
dentition. Reflected near infra-red light images of posterior (back
of the mouth) teeth were used to detect interproximal caries and
the results were then compared to bitewing radiography. NIRI was
found to be more sensitive than bitewing radiography in detecting
early enamel lesions and comparable in detecting dentinal
lesions.
Lead study author Dr. Zvi Metzger, Professor,
Departments of Oral Biology and Endodontology, at The Goldschleger
School of Dental Medicine, Tel Aviv University, commented on the
study findings: “Reflected near infra-red light images generated
simultaneously during 3D scanning of dental arches with the iTero
Element 5D imaging system scanner may be used reliably for
detection, screening and monitoring of proximal caries. This method
for caries detection may potentially minimize the traditional use
of ionizing radiation.”
Dr. Peggy Bown, a participant in the study,
shared that: “As a current user of the iTero Element 5D imaging
system, participating in the study was very beneficial to me. I
could further see the clinical value of the iTero Element 5D
imaging system through its high sensitivity at detecting early
enamel lesions and ease of use. Having one system, one scan, and
one tip eliminates the need for multiple devices, repetitive
sterilization, and minimizes the use of harmful radiation.”
The study described was sponsored by Align
Technology.
* iTero NIRI technology is the same across the
iTero Element 5D system and some configurations of iTero Element
Plus imaging systems since the wand, optics and software are the
same.** Data on file at Align Technology, September 2021*** Data on
file at Align Technology, February 2021
About Align Technology,
Inc.Align Technology designs, manufactures and offers the
Invisalign system, the most advanced clear aligner system in the
world, iTero intraoral scanners and services, and exocad CAD/CAM
software. These technology building blocks enable enhanced digital
orthodontic and restorative workflows to improve patient outcomes
and practice efficiencies for over 210 thousand doctor customers
and is key to accessing Align’s 500 million consumer market
opportunity worldwide. Align has helped doctors treat over 11.6
million patients with the Invisalign system and is driving the
evolution in digital dentistry through the Align Digital Platform,
our integrated suite of unique, proprietary technologies and
services delivered as a seamless, end-to-end solution for patients
and consumers, orthodontists and GP dentists, and lab/partners.
Visit www.aligntech.com for more information.
For additional information about the Invisalign
system or to find an Invisalign doctor in your area, please visit
www.invisalign.com. For additional information about iTero digital
scanning system, please visit www.itero.com. For additional
information about exocad dental CAD/CAM offerings and a list of
exocad reseller partners, please visit www.exocad.com.
Align TechnologyMadelyn Valente(408)
470-1180mvalente@aligntech.com |
|
Zeno GroupSarah Johnson(828)
551-4201sarah.johnson@zenogroup.com |
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