Impacted CaninesNCT05745766
2D Versus 3D Radiographs in the Localization of Upper Impacted Canines
An observational study of Impacted Canines, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 27 years
- Conditions the study is for
- Impacted Canines
- What is being tested?
- Panoramic and lateral cephalometric radiography, Cone beam computed tomography and Surgery
- How many people
- 17 participants
- Where
- 1 siteSyria
- Study dates
- 20 Jan 2016to 5 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who had a systemic disorder, cleft lip/cleft palate, craniofacial syndrome, traumatic injury, and congenital number anomaly.
- Patients had previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Oral and Maxillofacial Surgery, University of Damascus Faculty of Dentistry
Damascus
About this study
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
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.
Read the 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
- Impacted Canines
- Being tested
- Panoramic and lateral cephalometric radiography, Cone beam computed tomography, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panoramic and lateral cephalometric radiographyOther
The 2D-based assessments of the impacted maxillary canine will be achieved using panoramic and lateral cephalometric radiographs.
Cone beam computed tomographyOther
The 3D-based assessments of the impacted maxillary canine will be achieved using a cone beam computed tomography (CBCT) image.
SurgeryOther
The surgical exposure will be accomplished, and the impacted maxillary canine will be assessed by a direct vision.
| Study group | Role | What they receive |
|---|---|---|
| Canines assessed using 2D images | The 2D-based assessments of the impacted maxillary canine. Receives: Other: Panoramic and lateral cephalometric radiography | |
| Canines assessed using 3D images | The 3D-based assessments of the impacted maxillary canine. Receives: Other: Cone beam computed tomography | |
| Canines assessed intra-operatively or post-operatively | The gold standard-based assessments are based on surgical exposure. Receives: Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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°)
Measured: 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
Measured: 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.
Measured: The assessment will be performed after the extraction of the impacted maxillary canine, i.e., immediately following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start20 Jan 2016
- Primary completion12 Dec 2016
- Study completion5 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Impacted CaninesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayman Shaweesh, DDS MSc, Principal investigator, Department of Oral and Maxillofacial Surgery, Damascus University, SyriaDoa'a Tahseen Alfailany, DDS, Principal investigator, Department of orthodontics, Damascus University, SyriaMohammad Y. Hajeer, DDS MSc PhD, Study director, Department of orthodontics, Damascus University, SyriaBassel Brad, DDS MSc PhD, Study chair, Department of Oral and Maxillofacial Surgery, Damascus University, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745766
- Sponsor's protocol ID
- UDDS-Ortho-01-2023
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16214621Alqerban 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.
PubMed 26683426Al-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.
PubMed 26423501Botticelli 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.
PubMed 21131389Hajeer 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.
PubMed 35606269
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05745766
- Acronym / sponsor ID
- UDDS-Ortho-01-2023
- Conditions
- Impacted Canines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 5 Aug 2018 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Canines assessed using 2D images | – | Other: Panoramic and lateral cephalometric radiographyThe 2D-based assessments of the impacted maxillary canine. |
| Canines assessed using 3D images | – | Other: Cone beam computed tomographyThe 3D-based assessments of the impacted maxillary canine. |
| Canines assessed intra-operatively or post-operatively | – | Other: SurgeryThe gold standard-based assessments are based on surgical exposure. |
Who may qualify
- Ages
- 14 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who had a systemic disorder, cleft lip/cleft palate, craniofacial syndrome, traumatic injury, and congenital number anomaly.
- Patients had previous orthodontic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panoramic and lateral cephalometric radiographyThe 2D-based assessments of the impacted maxillary canine will be achieved using panoramic and lateral cephalometric radiographs. | Other | Canines assessed using 2D images |
| Cone beam computed tomographyThe 3D-based assessments of the impacted maxillary canine will be achieved using a cone beam computed tomography (CBCT) image. | Other | Canines assessed using 3D images |
| SurgeryThe surgical exposure will be accomplished, and the impacted maxillary canine will be assessed by a direct vision. | Other | Canines assessed intra-operatively or post-operatively |
Primary outcome
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
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.
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
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)
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)
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.
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
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°)
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Background: PubMed 16214621Walker 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.
- Background: PubMed 26683426Alqerban 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.
- Background: PubMed 26423501Al-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.
- Background: PubMed 21131389Botticelli 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.
- Background: PubMed 35606269Hajeer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Shaweesh, DDS MSc principal investigator
Department of Oral and Maxillofacial Surgery, Damascus University, Syria
Doa'a Tahseen Alfailany, DDS principal investigator
Department of orthodontics, Damascus University, Syria
Mohammad Y. Hajeer, DDS MSc PhD study director
Department of orthodontics, Damascus University, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impacted Canines, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05745766, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.