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CompletedNCT05745766

2D Versus 3D Radiographs in the Localization of Upper Impacted Canines

Evaluation of the Diagnostic Accuracy of Cone-beam Computed Tomography (CBCT) Imaging Compared to the Two-dimensional (2D) Methods in the 3D Localization and Assessment of Maxillary Impacted Canines: A Surgical-exposure-based Study

Status
Completed
Phase
Study type
Observational
Enrollment
17 (actual)
Sponsor
Damascus University · Academic / Other
Sex
All
Age
14 Years – 27 Years
Healthy volunteers
Not accepted

Summary

Seventeen patients diagnosed with the extraction-based treatment of impacted maxillary canines will be included in this study. Each patient will undergo conventional 2D radiography including panoramic, and lateral cephalometric, in addition to 3D imaging by cone beam computed tomography (CBCT) images. A set of variables will be evaluated on 2D and 3D images by a panel of assessors and then these results will be compared with the gold standard which will be established based on surgical detection and direct visualization of the impacted canine.

Detailed description

After taking the radiographic records, the impacted maxillary canines will be surgically exposed under local anesthesia where a full-thickness flap will be elevated from the buccal or palatal according to the initial radiographic diagnosis. After cleaning the work yard to achieve good visibility, the pre-extraction parameters will be recorded which will be included labiopalatal position, mesiodistal position, and vertical position of the canine cusp, in addition to ankyloses of the impacted maxillary canine, proximity to the adjacent teeth, resorption of the adjacent incisors induced by the impacted maxillary canine, and bony coverage of the canine crown. This will be followed by the extraction of the upper impacted canine and the recording of the post-extraction parameters, which will include the shape and the root apex development of the extracted canine. The pre- and post-extraction readings will be deemed the gold standard which will be compared to the 2D- and 3D-based assessments of the assessors. Assessment sessions will be divided into two sessions with a one-week break in between. The first session will be devoted to the evaluation of the 2D image sets, while the second one will be to the evaluation of the 3D images. Before beginning the assessment, the assessors will be subjected to a set of instructions and clarifications, including a set of graphs that help each assessor to accurately identify each variable, in addition to an oral explanation of some points so that the assessor will not fall into doubt when evaluating the radiographs.

Conditions

Interventions

TypeNameDescription
OTHERPanoramic and lateral cephalometric radiographyThe 2D-based assessments of the impacted maxillary canine will be achieved using panoramic and lateral cephalometric radiographs.
OTHERCone beam computed tomographyThe 3D-based assessments of the impacted maxillary canine will be achieved using a cone beam computed tomography (CBCT) image.
OTHERSurgeryThe surgical exposure will be accomplished, and the impacted maxillary canine will be assessed by a direct vision.

Timeline

Start date
2016-01-20
Primary completion
2016-12-12
Completion
2018-08-05
First posted
2023-02-27
Last updated
2023-02-27

Locations

1 site across 1 country: Syria

Source: ClinicalTrials.gov record NCT05745766. Inclusion in this directory is not an endorsement.

2D Versus 3D Radiographs in the Localization of Upper Impacted Canines (NCT05745766) · Clinical Trials Directory