Impacted Tooth With Abnormal PositioningNCT05891665
Evaluation of the Accelerated Traction of Impacted Canines in Terms of Speed and Changes in the Dental Arches
A study testing Corticotomy and Traditional traction of the impacted canine without corticotomy in people with Impacted Tooth With Abnormal Positioning, run by Damascus University at 1 site in Syria.
Trial summary
The time required for orthodontic traction of impacted canines after surgical exposure is a particularly troubling clinical problem because it prolongs the orthodontic treatment duration. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Impacted Tooth With Abnormal Positioning
- What is being tested?
- Corticotomy and Traditional traction of the impacted canine without corticotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSyria
- Study dates
- 15 Jan 2020to 12 Mar 2023
- 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 aged 18 to 28.
- Unilateral palatally or mid-alveolar upper impacted canine.
- The impacted canine crown not exceeding the middle of the lateral incisor root.
- Absence of root resorption of the lateral incisors.
- No contact between the canine crown and the lateral incisor root.
- Individuals not previously receiving orthodontic treatment.
- No use of any medications that may affect the orthodontic movement.
Who cannot join
- Bilateral or buccal canine impaction cases.
- More than 45-degree angle between the canine's longitudinal axis and the vertical facial plane.
- Any medical condition that prevents oral surgery.
- Oral structural abnormality that is inherited or congenital.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, University of Damascus Dental School
Damascus, DM20AM18
About this study
Official title: The Effectiveness of Minimally-invasive Corticotomy-assisted Orthodontic Treatment of Palatally Impacted Canines in Terms of Treatment Duration and Dentoalveolar Changes Compared to the Traditional Method: A Randomized Controlled Trial.
The time required for orthodontic traction of impacted canines after surgical exposure is a particularly troubling clinical problem because it prolongs the orthodontic treatment duration. During traction process, several complications could result in alveolar bone loss, root resorption of the adjacent teeth, ankylosis, discoloration, loss or vitality and gingival recession. Accordingly, and due to the lack of studies concerned with accelerating the traction movement of the impacted canines, we conducted this study to evaluate the effectiveness of some surgical interventions (corticotomy and Piezocision) in increasing the rate of orthodontic traction movement. We also aimed to evaluate dentoalveolar changes associated with the use of such accelerating procedures compared with the conventional traction method.
Read the detailed description
Adult patients with unilateral palatally impacted canines will be included in this study. One of patient groups will be treated using fixed orthodontic appliances in combination with some accelerated surgical interventions, while the second patient group will be treated using the traditional treatment method. The velocity of traction movement will be assessed in the two groups. The differences between the two groups in terms of the total treatment duration and the traction duration will be evaluated.
Dentoalveolar changes associated with the use of such accelerating procedures will be assessed by several variables studied on cone-beam computed tomography (CBCT) images. In this study, two groups are going to be evaluated: (1) patients treated in the traditional manner, (2) patients will undergo corticotomy-assisted traction of the impacted canines.
- Conditions
- Impacted Tooth With Abnormal Positioning
- Being tested
- Corticotomy, Traditional traction of the impacted canine without corticotomy
- Keywords
- Canine impaction, Acceleration of tooth movement, Corticotomy, Minimally invasive acceleration, Maxillary canine impaction, Withdrawal of an impacted canine, Piezosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticotomyProcedure or surgery
A corticotomy procedure will be applied with some osteoperforations during the surgical exposure of the impacted canine. Then this will be followed after 8 weeks with another surgical stimulation using piezosurgery.
Traditional traction of the impacted canine without corticotomyProcedure or surgery
In this group of patients, the traction of the impacted canine will be performed traditionally without the involvement of additional surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with the acceleration method | Experimental | Patients will be treated using fixed orthodontic appliances assisted by minimally-invasive corticotomy (osteoperforations and piezocision) to accelerate impacted canines' traction after levelling and aligning the upper dental arch and opening an appropriate distance. Receives: Procedure: Corticotomy |
| Patients treated with the traditional traction technique | Active comparator | Patients will be treated using the fixed orthodontic appliances to track the palatally impacted canines after levelling and aligning the upper dental arch and opening an appropriate space to receive the impacted canine. Receives: Procedure: Traditional traction of the impacted canine without corticotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traction time
The interval between the onset of orthodontic traction on the impacted canine and the emergence of half of its clinical crown.
Measured: At the end of the traction stage which is expected to happen within 6 to 8 months
Total treatment time
The time between the bonding of the fixed orthodontic appliance until it is removed.
Measured: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Velocity of the traction movement
Calculated by dividing the depth of impaction, which defined as the distance from the impacted canine cusp tip to the occlusal plane, by the traction duration
Measured: At the end of the traction stage which is expected to happen within 6 to 8 months
Secondary outcomes (5)
Bone support ratio of the aligned canine
Alveolar bone height is the distance from the root apex of the canine to the alveolar crest (measured in mm), and canine root length is the distance from the root apex of the canine to the midpoint of a line connecting the mesial and distal points on the cementoenamel junction (measured in mm). The ratio will be calculated by dividing the alveolar bone height by the canine root length.
Measured: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Bone support ratio of the contralateral naturally erupting canine
Alveolar bone height is the distance from the root apex of the naturally erupting canine to the alveolar crest (measured in mm), and canine root length is the distance from the root apex of the naturally erupting canine to the midpoint of a line connecting the mesial and distal points on the cementoenamel junction (measured in mm). The ratio will be calculated by dividing the alveolar bone height by the canine root length.
Measured: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Bone support ratio of the adjacent lateral incisor
Alveolar bone height is the distance from the root apex of the adjacent lateral incisor to the alveolar crest (measured in mm), and the lateral incisor's root length is the distance from the root apex of the lateral incisor to the midpoint of a line connecting the mesial and distal points on the cementoenamel junction (measured in mm). The ratio will be calculated by dividing the alveolar bone height by the lateral incisor's root length.
Measured: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Bone support ratio of the adjacent first premolar
Alveolar bone height is the distance from the root apex of the adjacent first premolar to the alveolar crest (measured in mm), and the first premolar's root length is the distance from the root apex of the first premolar to the midpoint of a line connecting the mesial and distal points on the cementoenamel junction (measured in mm). The ratio will be calculated by dividing the alveolar bone height by the first premolar root length.
Measured: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Change of the root length of the adjacent lateral incisor
Resorption of adjacent lateral root will be evaluated by comparing the root length before and after treatment.
Measured: (1) The first assessment time is at one day before the beginning of orthodontic treatment and the (2) second assessment time is at one week following the end of the orthodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start15 Jan 2020
- Primary completion1 Dec 2022
- Study completion12 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Impacted Tooth With Abnormal PositioningStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahran R. Mousa, DDS MSc, Principal investigator, PhD student at the Department of OrthodonticsMohammad Y Hajeer, DDS MSc PhD, Study chair, Professor of Orthodontics, Faculty of Dentistry, University of DamascusOmar Heshmeh, DDS MSc PhD, Study chair, Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891665
- Sponsor's protocol ID
- UDDS-Ortho-10-2023
- Status last verified
- May 2023
- First submitted
- 14 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Ibrahim HM, Hajeer MY, Alkhouri I, Zinah E. Leveling and alignment time and the periodontal status in patients with severe upper crowding treated by corticotomy-assisted self-ligating brackets in comparison with conventional or self-ligating brackets only: a 3-arm randomized controlled clinical trial. J World Fed Orthod. 2022 Feb;11(1):3-11. doi: 10.1016/j.ejwf.2021.09.002. Epub 2021 Oct 21.
PubMed 34688577Becker A, Chaushu S. Success rate and duration of orthodontic treatment for adult patients with palatally impacted maxillary canines. Am J Orthod Dentofacial Orthop. 2003 Nov;124(5):509-14. doi: 10.1016/s0889-5406(03)00578-x.
PubMed 14614417Becker A, Kohavi D, Zilberman Y. Periodontal status following the alignment of palatally impacted canine teeth. Am J Orthod. 1983 Oct;84(4):332-6. doi: 10.1016/s0002-9416(83)90349-4.
PubMed 6578683Smailiene D, Kavaliauskiene A, Pacauskiene I, Zasciurinskiene E, Bjerklin K. Palatally impacted maxillary canines: choice of surgical-orthodontic treatment method does not influence post-treatment periodontal status. A controlled prospective study. Eur J Orthod. 2013 Dec;35(6):803-10. doi: 10.1093/ejo/cjs102. Epub 2013 Jan 24.
PubMed 23349422Fischer 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 17465647Mousa MR, Hajeer MY, Burhan AS, Heshmeh O. The Effectiveness of Conventional and Accelerated Methods of Orthodontic Traction and Alignment of Palatally Impacted Canines in Terms of Treatment Time, Velocity of Tooth Movement, Periodontal, and Patient-Reported Outcomes: A Systematic Review. Cureus. 2022 May 10;14(5):e24888. doi: 10.7759/cureus.24888. eCollection 2022 May.
PubMed 35572459Parkin NA, Almutairi S, Benson PE. Surgical exposure and orthodontic alignment of palatally displaced canines: can we shorten treatment time? J Orthod. 2019 Jun;46(1_suppl):54-59. doi: 10.1177/1465312519841384. Epub 2019 Apr 1.
PubMed 31056030
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Minimally-invasive Corticotomy-assisted Orthodontic Treatment of Palatally Impacted Canines in Terms of Treatment Duration and Dentoalveolar Changes Compared to the Traditional Method: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05891665
- Acronym / sponsor ID
- UDDS-Ortho-10-2023
- Conditions
- Impacted Tooth With Abnormal Positioning
- Keywords
- Canine impaction, Acceleration of tooth movement, Corticotomy, Minimally invasive acceleration, Maxillary canine impaction, Withdrawal of an impacted canine, Piezosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 7 Jun 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.
The time required for orthodontic traction of impacted canines after surgical exposure is a particularly troubling clinical problem because it prolongs the orthodontic treatment duration. During traction process, several complications could result in alveolar bone loss, root resorption of the adjacent teeth, ankylosis, discoloration, loss or vitality and gingival recession. Accordingly, and due to the lack of studies concerned with accelerating the traction movement of the impacted canines, we conducted this study to evaluate the effectiveness of some surgical interventions (corticotomy and Piezocision) in increasing the rate of orthodontic traction movement. We also aimed to evaluate dentoalveolar changes associated with the use of such accelerating procedures compared with the conventional traction method.
Detailed description
Adult patients with unilateral palatally impacted canines will be included in this study. One of patient groups will be treated using fixed orthodontic appliances in combination with some accelerated surgical interventions, while the second patient group will be treated using the traditional treatment method. The velocity of traction movement will be assessed in the two groups. The differences between the two groups in terms of the total treatment duration and the traction duration will be evaluated.
Dentoalveolar changes associated with the use of such accelerating procedures will be assessed by several variables studied on cone-beam computed tomography (CBCT) images. In this study, two groups are going to be evaluated: (1) patients treated in the traditional manner, (2) patients will undergo corticotomy-assisted traction of the impacted canines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with the acceleration method | Experimental | Procedure: CorticotomyPatients will be treated using fixed orthodontic appliances assisted by minimally-invasive corticotomy (osteoperforations and piezocision) to accelerate impacted canines' traction after levelling and aligning the upper dental arch and opening an appropriate distance. |
| Patients treated with the traditional traction technique | Active comparator | Procedure: Traditional traction of the impacted canine without corticotomyPatients will be treated using the fixed orthodontic appliances to track the palatally impacted canines after levelling and aligning the upper dental arch and opening an appropriate space to receive the impacted canine. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients aged 18 to 28.
- Unilateral palatally or mid-alveolar upper impacted canine.
- The impacted canine crown not exceeding the middle of the lateral incisor root.
- Absence of root resorption of the lateral incisors.
- No contact between the canine crown and the lateral incisor root.
Key exclusion criteria (4 listed)
- Bilateral or buccal canine impaction cases.
- More than 45-degree angle between the canine's longitudinal axis and the vertical facial plane.
- Any medical condition that prevents oral surgery.
- Oral structural abnormality that is inherited or congenital.
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 |
|---|---|---|
| CorticotomyA corticotomy procedure will be applied with some osteoperforations during the surgical exposure of the impacted canine. Then this will be followed after 8 weeks with another surgical stimulation using piezosurgery. | Procedure or surgery | Patients treated with the acceleration method |
| Traditional traction of the impacted canine without corticotomyIn this group of patients, the traction of the impacted canine will be performed traditionally without the involvement of additional surgical intervention. | Procedure or surgery | Patients treated with the traditional traction technique |
Primary outcome
Traction time
Time frame: At the end of the traction stage which is expected to happen within 6 to 8 months
The interval between the onset of orthodontic traction on the impacted canine and the emergence of half of its clinical crown.
Total treatment time
Time frame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
The time between the bonding of the fixed orthodontic appliance until it is removed.
Velocity of the traction movement
Time frame: At the end of the traction stage which is expected to happen within 6 to 8 months
Calculated by dividing the depth of impaction, which defined as the distance from the impacted canine cusp tip to the occlusal plane, by the traction duration
5 secondary outcomes
Bone support ratio of the aligned canine
Time frame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Bone support ratio of the contralateral naturally erupting canine
Time frame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Bone support ratio of the adjacent lateral incisor
Time frame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Bone support ratio of the adjacent first premolar
Time frame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Change of the root length of the adjacent lateral incisor
Time frame: (1) The first assessment time is at one day before the beginning of orthodontic treatment and the (2) second assessment time is at one week following the end of the orthodontic treatment
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 7 Jun 2023.
- Background: PubMed 34688577Al-Ibrahim HM, Hajeer MY, Alkhouri I, Zinah E. Leveling and alignment time and the periodontal status in patients with severe upper crowding treated by corticotomy-assisted self-ligating brackets in comparison with conventional or self-ligating brackets only: a 3-arm randomized controlled clinical trial. J World Fed Orthod. 2022 Feb;11(1):3-11. doi: 10.1016/j.ejwf.2021.09.002. Epub 2021 Oct 21.
- Background: PubMed 14614417Becker A, Chaushu S. Success rate and duration of orthodontic treatment for adult patients with palatally impacted maxillary canines. Am J Orthod Dentofacial Orthop. 2003 Nov;124(5):509-14. doi: 10.1016/s0889-5406(03)00578-x.
- Background: PubMed 6578683Becker A, Kohavi D, Zilberman Y. Periodontal status following the alignment of palatally impacted canine teeth. Am J Orthod. 1983 Oct;84(4):332-6. doi: 10.1016/s0002-9416(83)90349-4.
- Background: PubMed 23349422Smailiene D, Kavaliauskiene A, Pacauskiene I, Zasciurinskiene E, Bjerklin K. Palatally impacted maxillary canines: choice of surgical-orthodontic treatment method does not influence post-treatment periodontal status. A controlled prospective study. Eur J Orthod. 2013 Dec;35(6):803-10. doi: 10.1093/ejo/cjs102. Epub 2013 Jan 24.
- 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 35572459Mousa MR, Hajeer MY, Burhan AS, Heshmeh O. The Effectiveness of Conventional and Accelerated Methods of Orthodontic Traction and Alignment of Palatally Impacted Canines in Terms of Treatment Time, Velocity of Tooth Movement, Periodontal, and Patient-Reported Outcomes: A Systematic Review. Cureus. 2022 May 10;14(5):e24888. doi: 10.7759/cureus.24888. eCollection 2022 May.
- Background: PubMed 31056030Parkin NA, Almutairi S, Benson PE. Surgical exposure and orthodontic alignment of palatally displaced canines: can we shorten treatment time? J Orthod. 2019 Jun;46(1_suppl):54-59. doi: 10.1177/1465312519841384. Epub 2019 Apr 1.
- 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 R. Mousa, DDS MSc principal investigator
PhD student at the Department of Orthodontics
Mohammad Y Hajeer, DDS MSc PhD study chair
Professor of Orthodontics, Faculty of Dentistry, University of Damascus
Omar Heshmeh, DDS MSc PhD study chair
Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, University of Damascus
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 Traditional traction of the impacted canine without corticotomy in people with Impacted Tooth With Abnormal Positioning, 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 7 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 7 Jun 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?
Traction time (time frame: At the end of the traction stage which is expected to happen within 6 to 8 months). The study lists 3 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 NCT05891665, which also lists 7 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 7 Jun 2023.