Diagnostic quality of hand held intra-oral radiography

Rationale: Mobile Hand held X-ray devices (HH) potentially provide advantages over fixed wall mounted devices (WM) for dental intra-oral radiography. Hand held devices can be used when visiting non-mobile patients or in part time dental clinics in remote, sparsely populated areas. Moreover, in the dental office, one HH device can serve multiple suites instead of one WM device for each suite. This limits financial investments potentially improving the accessibility of dental care. Recent studies have proved that with judicious use, Conformité Européenne (CE) approved devices such as the Nomad Pro 2, are safe for the operator and the patient. An issue that has not yet been clarified in an adequately conducted clinical study is whether diagnostic image quality resulting from the use of HH X-ray devices is not inferior to WM devices.
Objective: To test if diagnostic quality of radiography with HH devices is non-inferior to that of radiography with WM devices.
Study design: We compare the 2 diagnostic modalities in a cross over clinical experimental non inferiority study. Bitewing (BW) exposures are made twice, once with HH and once with WM in random order without changing any other factor. Blinded observers rate the pairs of images displayed side by side for their preference regarding diagnostic quality. Three outcomes are possible: preference for WM, for HH or no preference. These questions were additionally answered for three diagnostic quality criteria. The non-inferiority limit was set at 10% for HH (p< 0.05).
Study population: 205 adult (18 years and older, legally capable) subjects are recruited from patients of ACTA requiring bitewing radiographs who are consenting to participate after being properly informed.
Intervention: The intervention for the patient is that instead of one BW left side and one BW right side, two BW left side and two BW right side are performed. This means that the patient will have to bite down on a beam aiming device for circa 30 second longer for each side for the purpose of the study.
Main study parameters/endpoints: The preference of blinded observers for one of the two paired images regarding diagnostic image quality is recorded (HH pref, WM pref or no pref).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Apart from minor inconvenience due to the somewhat longer procedure the extra radiation dose poses a risk for the patient. The effective dose of a BW radiograph is 0.4 µSv.(Granlund et al.2016) By doubling the BW exposures the patient receives 0.8 µSv extra. By the standards of the ICRP this is a trivial risk.(ICRP 2007) No extra visits are necessary. There is no direct medical benefit for the patient of the extra BW. The research population is the same population the results of this research will apply to. As compensation for the invested time and effort the subjects will not be charged for the bitewing exposures

Dental intra-oral bitewing radiography with protable X-ray equipment is non-inferior to btewing radiography with wall mounted X-ray devices

Publication is accepted jan 2021 DMFR journal

An extra bitewing expoure is performed at left and right side of the patient