Diagnostic image quality of hand-held and wall-mounted X-ray devices in bitewing radiography: A non-inferiority clinical trial

Abstract

Objectives: The present clinical trial was intended to clarify whether subjective assessments of diagnostic X-ray image quality achieved via hand-held (HH) Nomad Pro 2 (KaVo Kerr, Brea, CA, USA) X-ray device is non-inferior that of the wall-mounted (WM) KaVo Focus (KaVo Dental, Bieberich, Germany). Methods: A prospective, cross-over, and in vivo non-inferiority clinical trial was conducted to compare these two diagnostic modalities. Based on sampling calculations, 205 patients were selected for study, generating 410 paired bitewing radiographs in randomized sequence. The films were assessed independently, engaging three observers blinded to modality for random, side-by-side-comparisons. Diagnostic image quality was rated as follows: no preference, HH preference, or WM preference. Observer judgements were combined accordingly to reach a majority. Results: Collective observer ratings indicated no preference for diagnostic image quality in 63.9% of cases, with WM preference at 16.6% and HH preference at 19.5%. The difference in HH and WM preferences (19.5%-16.6% = 2.9%) was within the expected 95% confidence interval. Majority agreement was reached in 82.7%. Conclusions: Subjectively assessed diagnostic image quality in bitewing radiographs acquired by HH and WM devices did not differ significantly. The hand-held device is thus non-inferior to the WM in this regard. Our data set of paired bitewing radiographs may subsequently aid in future research.