Comparing standard- and low-dose CBCT in diagnosis and treatment decisions for impacted mandibular third molars: a non-inferiority randomised clinical study

Abstract

Objective: This randomised clinical study aimed to assess the influence of low-dose cone-beam computed tomography (CBCT) on the visibility of the mandibular canal (MC) and its proximity to mandibular third molars (M3Ms) as assessed by general dental practitioners (GPs) and oral-maxillofacial surgeons (OMFSs), as well as its impact on their clinical decisions, when compared to standard-dose CBCT. Methods: 154 impacted M3Ms from 90 patients were randomly assigned to three groups for two CBCT exposures using one standard-dose (333 mGy×cm2) and one of the three investigated low-dose (78–131 mGy×cm2) protocols. Blinded assessments of the MC visibility, M3M-MC proximity, surgical approach, crown/root sectioning, and referral decisions, were made by GPs and OMFSs on the images separately. Pairwise comparisons for MC visibility between paired scans were evaluated using Wilcoxon signed rank test, followed by a non-inferiority test with non-inferiority margin of 0.5 on a four-point scale. Differences in other variables between paired scans were evaluated using Wilcoxon signed-rank or McNemar tests. Results: The majority (78.5–99.3%) of MCs were clearly identified on standard-dose CBCT by all observers. Pairwise comparisons showed significant differences between paired scans only in MC visibility but not in the M3M-MC proximity or treatment decisions. The mean differences in MC visibility between paired scans ranged 0-0.22 with the upper bounds of the 95% confidence intervals (0.09–0.36) falling within the non-inferiority region. Conclusions: The investigated low-dose CBCT protocols could provide acceptable image quality for the evaluation of impacted M3Ms in most cases. When compared to standard-dose CBCT, these low-dose CBCT images did not significantly affect the assessments of the M3M-MC proximity, treatment strategies, and patient management decisions made by GPs and OMFSs. Clinical relevance: The low-dose protocols might be clinically acceptable for M3M management while greatly reducing radiation exposure.