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)

• The study published in the Journal of Dentistry confirms that the iTero Element 5D imaging system* with iTero NIRI (Near Infra-Red Imaging) technology is more sensitive than bitewing radiography in detecting early enamel lesions and comparable in detecting dentinal lesions
• iTero NIRI technology of the iTero Element 5D imaging system was 66% more sensitive than bitewing X-ray for detection of interproximal lesions**

TEMPE, Ariz., Oct. 27, 2021 (GLOBE NEWSWIRE) -- 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.”