Align Technology shares findings from new clinical study demonstrating the significant benefits of the iTero Element 5D imaging system

Align Technology, Inc., 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, has announced the findings of a multi-centre 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 (24 October 2021). The study validates and further demonstrates the significant benefits of the iTero Element 5D imaging system, which the company asserted 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 by dentists using near infrared technology (NIRI) and bitewing radiography. 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%)***.

In addition, the study compared NIRI and bitewing radiography to visualise caries debridement. 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 visualisation 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 emphasises 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 in real time that aids in caries detection while simultaneously capturing 3D colour images of dentition.

Reflected near infrared light images of posterior 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 at Departments of Oral Biology and Endodontology, The Goldschleger School of Dental Medicine, Tel Aviv University (Israel), commented on the study findings: “Reflected near infrared 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 minimise the traditional use of ionising radiation.”

Dr Peggy Bown, a participant in the study, shared: “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 sterilisation, and minimises 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