Clinical trial NCT05745766: 2D Versus 3D Radiographs in the Localization of Upper Impacted Canines
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impacted Canines
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 17
Sex: ALL
Minimum age (years): 14
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with impacted canines. These canines should be located unilaterally. The orthodontic decision should include the removal of these impacted canines in the course of orthodontic treatment.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patients from both gender (Male and female), Age range: 14-27 years.
2. Unilateral impaction of the maxillary canines requiring surgical extraction.
3. Non-syndromic patients without any pathology of the maxillofacial region (benign or malignant tumor, cleft lip or cleft palate, trauma)
4. Patients with a set of panoramic and lateral cephalometric images, in addition to CBCT radiograph (CBCT is indicated for treatment planning)
5. The time period between taking the radiological records and undergoing the surgical intervention does not exceed four weeks

Exclusion Criteria:

1. Patients who had a systemic disorder, cleft lip/cleft palate, craniofacial syndrome, traumatic injury, and congenital number anomaly.
2. Patients had previous orthodontic treatment.

Primary outcomes:
measure: Labiopalatal position of the canine cusp
timeFrame: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
measure: Mesiodistal position of the canine cusp
timeFrame: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
measure: The vertical position of the canine cusp
timeFrame: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
measure: Ankylosis of the impacted maxillary canine
timeFrame: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
measure: Proximity to the adjacent teeth
timeFrame: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
measure: Resorption of the adjacent incisors induced by the impacted canine
timeFrame: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
measure: Bony coverage of the impacted maxillary canine
timeFrame: The assessment will be performed after the surgical exposure of the impacted maxillary canine and "during surgery", i.e., after 10 minutes of the surgical exposure.
measure: The shape of the extracted canine
timeFrame: The assessment will be performed after the extraction of the impacted maxillary canine, i.e., immediately following surgery
measure: Root apex closure of the extracted canine
timeFrame: The assessment will be performed after the extraction of the impacted maxillary canine, i.e., immediately following surgery
measure: Diagnostic accuracy, sensitivity, and specificity
timeFrame: The assessment will be performed after the extraction of the impacted maxillary canine, i.e., immediately following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Oral and Maxillofacial Surgery, University of Damascus Faculty of Dentistry
Study officials:
affiliation: Department of Oral and Maxillofacial Surgery, Damascus University, Syria
name: Ayman Shaweesh, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Doa'a Tahseen Alfailany, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Mohammad Y. Hajeer, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Department of Oral and Maxillofacial Surgery, Damascus University, Syria
name: Bassel Brad, DDS MSc PhD
role: STUDY_CHAIR
References:
citation: Walker L, Enciso R, Mah J. Three-dimensional localization of maxillary canines with cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2005 Oct;128(4):418-23. doi: 10.1016/j.ajodo.2004.04.033.
citation: Alqerban A, Storms AS, Voet M, Fieuws S, Willems G. Early prediction of maxillary canine impaction. Dentomaxillofac Radiol. 2016;45(3):20150232. doi: 10.1259/dmfr.20150232. Epub 2015 Dec 18.
citation: Al-Homsi HK, Hajeer MY. An Evaluation of Inter- and Intraobserver Reliability of Cone-beam Computed Tomography- and Two Dimensional-based Interpretations of Maxillary Canine Impactions using a Panel of Orthodontically Trained Observers. J Contemp Dent Pract. 2015 Aug 1;16(8):648-56. doi: 10.5005/jp-journals-10024-1736.
citation: Botticelli S, Verna C, Cattaneo PM, Heidmann J, Melsen B. Two- versus three-dimensional imaging in subjects with unerupted maxillary canines. Eur J Orthod. 2011 Aug;33(4):344-9. doi: 10.1093/ejo/cjq102. Epub 2010 Dec 3.
citation: Hajeer MY, Al-Homsi HK, Alfailany DT, Murad RMT. Evaluation of the diagnostic accuracy of CBCT-based interpretations of maxillary impacted canines compared to those of conventional radiography: An in vitro study. Int Orthod. 2022 Jun;20(2):100639. doi: 10.1016/j.ortho.2022.100639. Epub 2022 May 21.