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Completed

NCT Number: NCT05745766

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

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.

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Key information

Conditions

Impacted Canines

Age range

14 year–27 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Panoramic and lateral cephalometric radiography

Other

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

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.

SURGERY

Other

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

Primary outcomes

  1. Labiopalatal position of the canine cusp

    Time frame: 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.

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

  2. Mesiodistal position of the canine cusp

    Time frame: 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.

    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.

  3. The vertical position of the canine cusp

    Time frame: 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.

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

  4. Ankylosis of the impacted maxillary canine

    Time frame: 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.

    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)

  5. Proximity to the adjacent teeth

    Time frame: 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.

    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)

  6. Resorption of the adjacent incisors induced by the impacted canine

    Time frame: 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.

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

  7. Bony coverage of the impacted maxillary canine

    Time frame: 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.

    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

  8. The shape of the extracted canine

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

    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°)

  9. Root apex closure of the extracted canine

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

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

  10. Diagnostic accuracy, sensitivity, and specificity

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

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

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2018
First posted
Feb 27, 2023
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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