Impaction of ToothNCT07294378
Dental Changes Following the Traction of Impacted Maxillary Canines
A study testing Corticotomy and Conventional traction in people with Impaction of Tooth, run by Damascus University at 1 site in Syria.
Trial summary
The impaction of maxillary canines is a challenge for orthodontists. Recently, new methods have been proposed to accelerate canine withdrawal. The associated dental changes between the conventional and accelerated methods of canine traction have not yet been assessed. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Impaction of Tooth
- What is being tested?
- Corticotomy and Conventional traction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSyria
- Study dates
- 2 Mar 2023to 19 Jan 2025
- Phase
- Interventional
- 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 18 to 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients' ages ranged from 18 to 28 years old
- unilaterally palatally or mid-alveolar upper impacted canine
- patients who have never received orthodontic treatment previously
- mild crowding of the maxillary arch (less than 4 mm) and class I first molars relation
Who cannot join
- bilateral or buccal canine impaction
- patients who have a contraindication to perform oral surgery under local anesthesia (social, psychological, mor edical)
- more than 45-degree angle between the longitudinal axis of the impacted canines and the facial midline
- bad oral health
Trial locations and contacts
1 site in 1 country.
Syria1 site
Orthodontics Department, Faculty of Dentistry
Damascus, Rif-dimashq Governorate, DM20AM19
About this study
Official title: Evaluation of the Dental Changes Associated With the Traction of Palatally Impacted Canines Using the Conventional Versus the Corticotomy-assisted Method: A Randomized Controlled Trial
The impaction of maxillary canines is a challenge for orthodontists. Recently, new methods have been proposed to accelerate canine withdrawal. The associated dental changes between the conventional and accelerated methods of canine traction have not yet been assessed.
Read the detailed description
Impacted canines are defined as those that have not erupted within 6 six months after completing the formation of their roots or that were not present within the dental arch during their eruption phase. Upper Impacted canines are present in 2% of the general population and occur in females at a rate of 1.17%, which is almost twice the incidence in males. The incidence of palatal impaction ranges from 60% to 80% and is present bilaterally with a rate of 75-95%. The upper canines usually erupt at an average age of 10.5 years in females and 11.5 years in males, with an individual difference of 3-4 years. Eruption failure of the upper canines occurs because of hard or soft tissue obstructions or an abnormal eruption pathway.
The most important causes of palatally impaction of upper canines are dental arch length deficiency, over-retained primary teeth, and trauma during the canine formation stage. One local mechanical cause is a decrease in the width of the upper dental arch. McConnell et al. reported that patients with upper impacted canines had a reduction in dental arch width, especially in the anterior region. On the other hand, unilateral or bilateral upper canine impaction can affect upper dental arch width and alter smile symmetry.
The impaction of the upper canine is also considered as one of the causes that lead to a lack of transverse development of the maxillary dental arch, especially the inter-premolar width. This is supported by the functional matrix theory, which considers that the presence of the organ stimulates bone growth. Thus, the natural eruption of the canine stimulates the normal transverse growth of the dental arch.
Many treatment strategies were used to treat impacted canine cases, but orthodontic traction after surgical exposure was the most commonly recommended method in the literature, given the great aesthetic and functional value of the upper canines. Two main surgical methods are used for this purpose: the open and closed surgical approaches.
Several mechanical means have been used to obtain the traction force. However, choosing the appropriate mechanical method that produces the least undesirable effects on adjacent teeth was a challenge for the clinical practitioner.
Many factors could result in unwanted changes in the spatial position of the adjacent teeth, such as the use of an open coil spring, direct reliance on these teeth to tract the impacted canine, the type of baseline orthodontic archwire used, and the type of orthodontic anchorage means. These side effects on adjacent teeth can be minimized by using techniques such as the segmented archwire technique and temporary anchorage devices (TADs).
- Conditions
- Impaction of Tooth
- Being tested
- Corticotomy, Conventional traction
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticotomyProcedure or surgery
Also called flapless corticotomy, piezocision, piezosurgery
During the surgical exposure phase in the acceleration group, the cortical bone will be perforated around the exposed canine crown (6-8 holes) wherever possible-this procedure aims to accelerate the withdrawal movement of the impacted canine. A 1 mm round bur will be used to create circular holes (1 mm in diameter, 1-2 mm in depth, and spaced about 1.5 mm apart). After two months of the surgical exposure, the second acceleration procedure will be performed. Two or three vertical incisions (8 mm height) will be made using a surgical scalpel at the buccal side of the impaction area. The cortical cuts (2-3 mm in depth, 1 mm in width, and spaced about 2 mm apart) will be performed using a flapless piezosurgery technique along the vertical lines.
Conventional tractionProcedure or surgery
The canines will be withdrawn using conventional methods without any surgical acceleration.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated canine traction group | Experimental | Perforations of the bone surrounding the impacted canine will be conducted at the time of canine exposure. Two months later, another flapless corticotomy procedure will be performed during the withdrawal of the impacted canine. Receives: Procedure: Corticotomy |
| Conventional canine traction | Active comparator | The canines will be withdrawn to the dental arch using the conventionnal method without subjecitng the patient to any additional surgical intervention. Receives: Procedure: Conventional traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the upper dental midline deviation
The deviation of the upper dental midline will be measured in millimeters as the distance from the maxillary central incisors contact point to the maxillary model midline. This will be performed on the plaster models.
Measured: T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)
Change in the rotation of the lateral incisor.
The rotation will be measured in degrees as the angle between the maxillary model midline and the line connecting the mesial-distal marginal points of the adjacent lateral incisor.
Measured: T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)
Change in the rotation of the first premolar
The rotation will be measured in degrees as the angle between the maxillary model midline and the line connecting the mesial-distal marginal points of the adjacent first premolar.
Measured: T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)
Change in the inter-premolar width
Inter-premolar width will be measured in millimeters as the distance from the deepest point in the central groove of the adjacent first premolar and its counterpart on the contralateral side
Measured: T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start2 Mar 2023
- Primary completion15 Oct 2024
- Study completion19 Jan 2025
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 Impaction of ToothStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahran Raheel Mousa, DDS, MSc, PhD, Principal investigator, Department of Orthodontics, Faculty of Dentistry, Al-Hawash Private University, Homs, SyriaMohammad Younis Hajeer, DDS, MSc, PhD, Study director, Department of Orthodontics, Faculty of Dentistry, Damascus UniversityOmar Ahmad Heshmeh, DDS, MSc, PhD, Study director, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294378
- Sponsor's protocol ID
- UDDS-2025-Ortho-11
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fischer TJ. Orthodontic treatment acceleration with corticotomy-assisted exposure of palatally impacted canines. Angle Orthod. 2007 May;77(3):417-20. doi: 10.2319/0003-3219(2007)077[0417:OTAWCE]2.0.CO;2.
PubMed 17465647Alyafrusee ES, Zheng B, Almashraqi AA, Almaqrami BS, Yang X, Xu H, Alhammadi MS, Liu Y. Three-dimensional dentoalveolar characteristics of a labially impacted dilacerated maxillary central incisor using cone-beam computed tomography. Sci Rep. 2025 Jul 9;15(1):24669. doi: 10.1038/s41598-025-10043-9.
PubMed 40634539Hocevar M, Ovsenik M, Golez A. Position of Maxillary Lateral Incisor and First Premolar in Impaction of Maxillary Canines: A Controlled Clinical CBCT and 3D Study Model Analysis. Dent J (Basel). 2025 Oct 27;13(11):497. doi: 10.3390/dj13110497.
PubMed 41294478Mousa MR, Hajeer MY, Burhan AS, Heshmeh O. Adult periodontal comparison after treatment of palatally impacted canines aligned by conventional or accelerated minimally-invasive corticotomy-assisted orthodontic traction: A randomized controlled trial. Int Orthod. 2023 Sep;21(3):100785. doi: 10.1016/j.ortho.2023.100785. Epub 2023 Jun 15.
PubMed 37329591Mousa MR, Hajeer MY, Burhan AS, Heshmeh O, Alam MK. The effectiveness of minimally-invasive corticotomy-assisted orthodontic treatment of palatally impacted canines compared to the traditional traction method in terms of treatment duration, velocity of traction movement and the associated dentoalveolar changes: A randomized controlled trial. F1000Res. 2023 Jun 19;12:699. doi: 10.12688/f1000research.135338.1. eCollection 2023.
PubMed 37920456
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dental Changes Associated With the Traction of Palatally Impacted Canines Using the Conventional Versus the Corticotomy-assisted Method: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07294378
- Acronym / sponsor ID
- UDDS-2025-Ortho-11
- Conditions
- Impaction of Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 19 Jan 2025 (actual)
- First posted
- 19 Dec 2025 (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.
The impaction of maxillary canines is a challenge for orthodontists. Recently, new methods have been proposed to accelerate canine withdrawal. The associated dental changes between the conventional and accelerated methods of canine traction have not yet been assessed.
Detailed description
Impacted canines are defined as those that have not erupted within 6 six months after completing the formation of their roots or that were not present within the dental arch during their eruption phase. Upper Impacted canines are present in 2% of the general population and occur in females at a rate of 1.17%, which is almost twice the incidence in males. The incidence of palatal impaction ranges from 60% to 80% and is present bilaterally with a rate of 75-95%. The upper canines usually erupt at an average age of 10.5 years in females and 11.5 years in males, with an individual difference of 3-4 years. Eruption failure of the upper canines occurs because of hard or soft tissue obstructions or an abnormal eruption pathway.
The most important causes of palatally impaction of upper canines are dental arch length deficiency, over-retained primary teeth, and trauma during the canine formation stage. One local mechanical cause is a decrease in the width of the upper dental arch. McConnell et al. reported that patients with upper impacted canines had a reduction in dental arch width, especially in the anterior region. On the other hand, unilateral or bilateral upper canine impaction can affect upper dental arch width and alter smile symmetry.
The impaction of the upper canine is also considered as one of the causes that lead to a lack of transverse development of the maxillary dental arch, especially the inter-premolar width. This is supported by the functional matrix theory, which considers that the presence of the organ stimulates bone growth. Thus, the natural eruption of the canine stimulates the normal transverse growth of the dental arch.
Many treatment strategies were used to treat impacted canine cases, but orthodontic traction after surgical exposure was the most commonly recommended method in the literature, given the great aesthetic and functional value of the upper canines. Two main surgical methods are used for this purpose: the open and closed surgical approaches.
Several mechanical means have been used to obtain the traction force. However, choosing the appropriate mechanical method that produces the least undesirable effects on adjacent teeth was a challenge for the clinical practitioner.
Many factors could result in unwanted changes in the spatial position of the adjacent teeth, such as the use of an open coil spring, direct reliance on these teeth to tract the impacted canine, the type of baseline orthodontic archwire used, and the type of orthodontic anchorage means. These side effects on adjacent teeth can be minimized by using techniques such as the segmented archwire technique and temporary anchorage devices (TADs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated canine traction group | Experimental | Procedure: CorticotomyPerforations of the bone surrounding the impacted canine will be conducted at the time of canine exposure. Two months later, another flapless corticotomy procedure will be performed during the withdrawal of the impacted canine. |
| Conventional canine traction | Active comparator | Procedure: Conventional tractionThe canines will be withdrawn to the dental arch using the conventionnal method without subjecitng the patient to any additional surgical intervention. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients' ages ranged from 18 to 28 years old
- unilaterally palatally or mid-alveolar upper impacted canine
- patients who have never received orthodontic treatment previously
- mild crowding of the maxillary arch (less than 4 mm) and class I first molars relation
Key exclusion criteria (4 listed)
- bilateral or buccal canine impaction
- patients who have a contraindication to perform oral surgery under local anesthesia (social, psychological, mor edical)
- more than 45-degree angle between the longitudinal axis of the impacted canines and the facial midline
- bad oral health
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 |
|---|---|---|
| CorticotomyAlso: flapless corticotomy, piezocision, piezosurgeryDuring the surgical exposure phase in the acceleration group, the cortical bone will be perforated around the exposed canine crown (6-8 holes) wherever possible-this procedure aims to accelerate the withdrawal movement of the impacted canine. A 1 mm round bur will be used to create circular holes (1 mm in diameter, 1-2 mm in depth, and spaced about 1.5 mm apart). After two months of the surgical exposure, the second acceleration procedure will be performed. Two or three vertical incisions (8 mm height) will be made using a surgical scalpel at the buccal side of the impaction area. The cortical cuts (2-3 mm in depth, 1 mm in width, and spaced about 2 mm apart) will be performed using a flapless piezosurgery technique along the vertical lines. | Procedure or surgery | Accelerated canine traction group |
| Conventional tractionThe canines will be withdrawn using conventional methods without any surgical acceleration. | Procedure or surgery | Conventional canine traction |
Primary outcome
Change in the upper dental midline deviation
Time frame: T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)
The deviation of the upper dental midline will be measured in millimeters as the distance from the maxillary central incisors contact point to the maxillary model midline. This will be performed on the plaster models.
Change in the rotation of the lateral incisor.
Time frame: T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)
The rotation will be measured in degrees as the angle between the maxillary model midline and the line connecting the mesial-distal marginal points of the adjacent lateral incisor.
Change in the rotation of the first premolar
Time frame: T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)
The rotation will be measured in degrees as the angle between the maxillary model midline and the line connecting the mesial-distal marginal points of the adjacent first premolar.
Change in the inter-premolar width
Time frame: T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)
Inter-premolar width will be measured in millimeters as the distance from the deepest point in the central groove of the adjacent first premolar and its counterpart on the contralateral side
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 29 Dec 2025.
- Background: PubMed 17465647Fischer TJ. Orthodontic treatment acceleration with corticotomy-assisted exposure of palatally impacted canines. Angle Orthod. 2007 May;77(3):417-20. doi: 10.2319/0003-3219(2007)077[0417:OTAWCE]2.0.CO;2.
- Background: PubMed 40634539Alyafrusee ES, Zheng B, Almashraqi AA, Almaqrami BS, Yang X, Xu H, Alhammadi MS, Liu Y. Three-dimensional dentoalveolar characteristics of a labially impacted dilacerated maxillary central incisor using cone-beam computed tomography. Sci Rep. 2025 Jul 9;15(1):24669. doi: 10.1038/s41598-025-10043-9.
- Background: PubMed 41294478Hocevar M, Ovsenik M, Golez A. Position of Maxillary Lateral Incisor and First Premolar in Impaction of Maxillary Canines: A Controlled Clinical CBCT and 3D Study Model Analysis. Dent J (Basel). 2025 Oct 27;13(11):497. doi: 10.3390/dj13110497.
- Background: PubMed 37329591Mousa MR, Hajeer MY, Burhan AS, Heshmeh O. Adult periodontal comparison after treatment of palatally impacted canines aligned by conventional or accelerated minimally-invasive corticotomy-assisted orthodontic traction: A randomized controlled trial. Int Orthod. 2023 Sep;21(3):100785. doi: 10.1016/j.ortho.2023.100785. Epub 2023 Jun 15.
- Background: PubMed 37920456Mousa MR, Hajeer MY, Burhan AS, Heshmeh O, Alam MK. The effectiveness of minimally-invasive corticotomy-assisted orthodontic treatment of palatally impacted canines compared to the traditional traction method in terms of treatment duration, velocity of traction movement and the associated dentoalveolar changes: A randomized controlled trial. F1000Res. 2023 Jun 19;12:699. doi: 10.12688/f1000research.135338.1. eCollection 2023.
- 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.
Mahran Raheel Mousa, DDS, MSc, PhD principal investigator
Department of Orthodontics, Faculty of Dentistry, Al-Hawash Private University, Homs, Syria
Mohammad Younis Hajeer, DDS, MSc, PhD study director
Department of Orthodontics, Faculty of Dentistry, Damascus University
Omar Ahmad Heshmeh, DDS, MSc, PhD study director
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticotomy and Conventional traction in people with Impaction of Tooth, 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 4 inclusion and 4 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 29 Dec 2025. 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?
Change in the upper dental midline deviation (time frame: T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)). The study lists 4 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 NCT07294378, 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 29 Dec 2025.