Align Technology announced the findings of a multi-centre clinical study that validates and 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 compares the detection of interproximal caries by dentists using near infra-red technology (NIRI) and bitewing radiography.
The results demonstrate 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 visual caries debridement (clinical removal of tooth decay).
When compared against clinical evaluation of posterior proximal lesions, the NIRI technology of the Itero Element 5D imaging system was 66%** more sensitive than bitewing X-ray technology. And it 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,’ said Yuval Shaked, senior vice president and managing director, Itero scanner and services business, Align Technology.
‘The visualisation capabilities of the Itero Element 5D imaging system helps in the early detection of cavities without X-ray radiation.
‘This study emphasises the valuable role that the Itero 5D imaging system with NIRI technology is already providing doctors and their staff. It is helping support their dental assessments of patients and overall patient oral healthcare and treatment options.
‘The ease of use and comfortable experience for a broad population of patients makes the Itero 5D imaging system with NIRI technology an essential tool for any doctor’s practice.’
What did the study involve?
As part of the study, the Itero Element 5D imaging system performed intraoral scans on 100 patients in five dental clinics across Germany and Canada.
The Itero Element 5D imaging system includes NIRI technology. This scans the internal structure of a tooth (enamel and dentine) in real time. It aids in caries detection, while simultaneously capturing 3D colour images of dentition.
Reflected near infra-red light images of posterior (back of the mouth) teeth help detect interproximal caries. The results were then compared to bitewing radiography.
NIRI was 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 minimise the traditional use of ionising 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. Particularly 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 and repetitive sterilisation. It also minimises the use of harmful radiation.’
* 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