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

NCT05745766 | Completed DMC

• 1 other identifier: UDDS-Ortho-01-2023
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Impacted Canines

Outcome Measures

Primary Outcomes (10)

• Labiopalatal position of the canine cusp

  Assessment will be performed relative to the adjacent teeth based on classification into three categories: 1-Labial, 2-In situ, 3- Palatal

  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.

• Mesiodistal position of the canine cusp

  Assessment will be performed based on classification into five sectors: Section (B') From the distal margin of the central incisor to the midline of the Palatine. Section (B) Between the mesial and distal margins of the lateral incisor on the same side of the impaction. Section (A) Between the distal of the lateral incisor and the mesial of the 1st premolar on the same side of the impaction. Section (C) Between the mesial and distal margins of the 1st premolar on the same side of the impaction. Section (C') Between the distal of the 1st premolar and the distal of the 2nd premolar.

  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.

• The vertical position of the canine cusp

  Assessment will be performed based on classification into three categories: 1-The cervical third, 2-The middle third, 3-The apical third

  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.

• Ankylosis of the impacted maxillary canine

  Assessment will be performed based on periodontal ligament distance (the canine root will be considered ankylosis if the periodontal ligament distance is equal to zero)

  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.

• Proximity to the adjacent teeth

  Assessment will be performed based on contact with the root of the adjacent incisor (the canine will be considered in contact when the space by 0 mm or less than 0.5 mm)

  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.

• Resorption of the adjacent incisors induced by the impacted canine

  Assessment will be performed based on the presence or absence of resorption in the adjacent teeth.

  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.

• Bony coverage of the impacted maxillary canine

  Assessment will be performed based on the classification of the bony coverage amount of the impacted canine crown into: 1- Completely covered with bone, 2- Partially covered with bone, 3- Uncovered

  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.

• The shape of the extracted canine

  Assessment will be performed based on the angle between the long axis of both the root and the crown and it will be classified into: 1-Straight (0°-10°), 2-Mildly curved (10°-30°), 3-Severe curved (\>30°)

  The assessment will be performed after the extraction of the impacted maxillary canine, i.e., immediately following surgery

• Root apex closure of the extracted canine

  Assessment will be performed based on classification into two categories: 1-Open apex, 2- Closed apex

  The assessment will be performed after the extraction of the impacted maxillary canine, i.e., immediately following surgery

• Diagnostic accuracy, sensitivity, and specificity

  Values of the parameters were assessed using CBCT and 2D radiographs.

  The assessment will be performed after the extraction of the impacted maxillary canine, i.e., immediately following surgery

Study Arms (3)

Canines assessed using 2D images

The 2D-based assessments of the impacted maxillary canine.

Other: Panoramic and lateral cephalometric radiography

Canines assessed using 3D images

The 3D-based assessments of the impacted maxillary canine.

Other: Cone beam computed tomography

Canines assessed intra-operatively or post-operatively

The gold standard-based assessments are based on surgical exposure.

Other: Surgery

Interventions

Panoramic and lateral cephalometric radiography OTHER

The 2D-based assessments of the impacted maxillary canine will be achieved using panoramic and lateral cephalometric radiographs.

Canines assessed using 2D images

Cone beam computed tomography OTHER

The 3D-based assessments of the impacted maxillary canine will be achieved using a cone beam computed tomography (CBCT) image.

Canines assessed using 3D images

Surgery OTHER

The surgical exposure will be accomplished, and the impacted maxillary canine will be assessed by a direct vision.

Canines assessed intra-operatively or post-operatively

Eligibility Criteria

• Age: 14 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Oral and Maxillofacial Surgery, University of Damascus Faculty of Dentistry

Damascus, Syria

Location

Related Publications (5)

• 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.

  PMID: 16214621 BACKGROUND

• 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.

  PMID: 26683426 BACKGROUND

• 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.

  PMID: 26423501 BACKGROUND

• 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.

  PMID: 21131389 BACKGROUND

• 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.

  PMID: 35606269 BACKGROUND

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Ayman Shaweesh, DDS MSc

  Department of Oral and Maxillofacial Surgery, Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• Doa'a Tahseen Alfailany, DDS

  Department of orthodontics, Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y. Hajeer, DDS MSc PhD

  Department of orthodontics, Damascus University, Syria

  STUDY DIRECTOR

• Bassel Brad, DDS MSc PhD

  Department of Oral and Maxillofacial Surgery, Damascus University, Syria

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 27, 2023
• Study Start: January 20, 2016
• Primary Completion: December 12, 2016
• Study Completion: August 5, 2018
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)