Impaction of ToothNCT03678805

The Effect of Surgical Interventions to Assist Orthodontic Movement of Impacted Maxillary Canines

A study testing Corticotomy and Traditional withdrawal techniques in people with Impaction of Tooth, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 to 30 years
Conditions the study is for: Impaction of Tooth
What is being tested?: Corticotomy and Traditional withdrawal techniques
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSyria
Study dates: 2 Jul 2018to 5 Feb 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 15 to 30 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Palatal or Mid-alveolar impacted canine.
There is no previous orthodontic treatment.
Healthy periodontal tissues and good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness(1963)).
No consumption of any drug that may interfere with the tooth movement (Cortisone, NSAIDs, …).
Mild or no crowding in the upper jaw.
No history of previous trauma to the maxillofacial region or surgical interventions.

Who cannot join

Any systemic diseases that would affect tooth movement
Antidepressant prevents oral surgery
Any congenital syndromes or cleft lip and palate cases
Bad oral health
Previous orthodontic treatment

Trial locations and contacts

1 site in 1 country.

Syria1 site

Department of Orthodontics, University of Damascus Dental School
Damascus, DM20AM18

Other trials in Syria

About this study

Official title: Evaluation of the Efficiency of Minimally-invasive Surgically-assisted Withdrawal of Palatally Impacted Maxillary Canines in Terms of Movement Velocity and Dento-alveolar Changes: A Randomized Controlled Clinical Trial

Impacted canine causes many problems for patients, such as absorption and damages to the adjacent teeth roots, as well as aesthetic problems. Correction of this problem requires a lengthy time. Therefore, many methods have been suggested to accelerate the movement of impacted canines with the help of surgical procedures.

Conditions: Impaction of Tooth
Being tested: Corticotomy, Traditional withdrawal techniques
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
Perforations in the areas close to the impacted canines will be performed in order to accelerate tooth movement.
Traditional withdrawal techniquesProcedure or surgery
The impacted canines will be withdrawn using elastic modules.

Study groups in NCT03678805
Study group	Role	What they receive
Acceleration	Experimental	The impacted canines will undergo acceleration by corticotomy accompanied with traditional traction techniques. Receives: Procedure: Corticotomy
Traditional Traction	Active comparator	Traditional traction will be employed in this group of patients with impacted canines. Traditional withdrawal techniques will be used. Receives: Procedure: Traditional withdrawal techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Canine Traction
The time required in days will be calculated from the beginning of canine traction till the end of canine alignment in its place in the dental arch.
Measured: The required time (in days) to achieve complete alignment of the impacted canine will be calculated which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group
Change in Canine Location in the Axial View
The distance between the cusp tip of the impacted canine to the palatal mid-line in the axial view using cone-beam computed tomography (CBCT) imaging.
Measured: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
Change in Canine Inclination in the Coronal View
The mesiodistal inclination of the impacted canine will be calculated which is the angle between the long axis of the impacted canine and the mid-sagittal plane in the coronal view of the cone-beam computed tomography (CBCT) imaging.
Measured: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
Change in the Canine Inclination in the Sagittal View
The labiopalatal inclination of the impacted canine: will be calculated which is the angle between the long axis of the impacted canine and a line perpendicular to the horizontal plane in the sagittal view of the cone-beam computed tomography (CBCT) imaging.
Measured: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
Change in the 3D Canine Location
The vertical distance from the cusp tip of the impacted canine to the upper occlusion plane is measured using the 3D volumetric rendered model of the cone-beam computed tomography (CBCT) imaging.
Measured: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
Relation to adjacent teeth
The contact between the impacted canine and the central and/or the lateral incisor will be evaluated by looking at the shortest distance between the impacted canine crown and the adjacent incisors' roots This will be done using sequential axial views on the cone-beam computed tomography (CBCT) imaging.
Measured: Just one day before the beginning of treatment
Change in the Absorption to the adjacent roots
Absorption of adjacent roots will be evaluated as follows:
In the axial views: an estimation of root damage will be taken into account and will be combined with an estimation of the vertical root damage using 3D volumetric rendered models and then will be classified into one of the four categories Class I: cementum involvement only and located at the apical third of the root Class II: involvement reaching the dentin but vertically less than one-third of the root length.
Class III: involvement reaching the dentin and partially the pulp but still vertically less than one-third of the root length.
Class IV: involvement reaching the root pulp and damaging more than one third of the root length vertically.
Measured: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 20185 Feb 2023

First posted20 Sep 2018
Study start2 Jul 2018
Primary completion20 Jun 2021
Study completion5 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03678805
Sponsor's protocol ID: UDDS-Ortho-19 -2018
Status last verified: Feb 2023
First submitted: 17 Sep 2018
Last updated: 9 Feb 2023
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 17465647
Sukh R, Singh GP, Tandon P. Interdisciplinary approach for the management of bilaterally impacted maxillary canines. Contemp Clin Dent. 2014 Oct;5(4):539-44. doi: 10.4103/0976-237X.142828.
PubMed 25395776
Shastri D, Nagar A, Tandon P. Alignment of palatally impacted canine with open window technique and modified K-9 spring. Contemp Clin Dent. 2014 Apr;5(2):272-4. doi: 10.4103/0976-237X.132362.
PubMed 24963263
Baccetti T, Leonardi M, Armi P. A randomized clinical study of two interceptive approaches to palatally displaced canines. Eur J Orthod. 2008 Aug;30(4):381-5. doi: 10.1093/ejo/cjn023. Epub 2008 Jun 3.
PubMed 18524761
Leonardi M, Armi P, Franchi L, Baccetti T. Two interceptive approaches to palatally displaced canines: a prospective longitudinal study. Angle Orthod. 2004 Oct;74(5):581-6. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
PubMed 15529490
Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.
PubMed 22105680
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 16214621
Smailiene 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 23349422
Alqerban A, Jacobs R, van Keirsbilck PJ, Aly M, Swinnen S, Fieuws S, Willems G. The effect of using CBCT in the diagnosis of canine impaction and its impact on the orthodontic treatment outcome. J Orthod Sci. 2014 Apr;3(2):34-40. doi: 10.4103/2278-0203.132911.
PubMed 24987661

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Impaction of Tooth trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficiency of Minimally-invasive Surgically-assisted Withdrawal of Palatally Impacted Maxillary Canines in Terms of Movement Velocity and Dento-alveolar Changes: A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT03678805
Acronym / sponsor ID: UDDS-Ortho-19 -2018
Conditions: Impaction of Tooth
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 2 Jul 2018 (actual)
Primary completion: 20 Jun 2021 (actual)
Study completion: 5 Feb 2023 (actual)
First posted: 20 Sep 2018 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Acceleration	Experimental	Procedure: CorticotomyThe impacted canines will undergo acceleration by corticotomy accompanied with traditional traction techniques.
Traditional Traction	Active comparator	Procedure: Traditional withdrawal techniquesTraditional traction will be employed in this group of patients with impacted canines. Traditional withdrawal techniques will be used.

Who may qualify

Ages: 15 to 30 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Palatal or Mid-alveolar impacted canine.
There is no previous orthodontic treatment.
Healthy periodontal tissues and good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness(1963)).
No consumption of any drug that may interfere with the tooth movement (Cortisone, NSAIDs, …).
Mild or no crowding in the upper jaw.

Key exclusion criteria (5 listed)

Any systemic diseases that would affect tooth movement
Antidepressant prevents oral surgery
Any congenital syndromes or cleft lip and palate cases
Bad oral health
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
CorticotomyPerforations in the areas close to the impacted canines will be performed in order to accelerate tooth movement.	Procedure or surgery	Acceleration
Traditional withdrawal techniquesThe impacted canines will be withdrawn using elastic modules.	Procedure or surgery	Traditional Traction

Primary outcome

Duration of Canine Traction
Time frame: The required time (in days) to achieve complete alignment of the impacted canine will be calculated which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group
The time required in days will be calculated from the beginning of canine traction till the end of canine alignment in its place in the dental arch.
Change in Canine Location in the Axial View
Time frame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
The distance between the cusp tip of the impacted canine to the palatal mid-line in the axial view using cone-beam computed tomography (CBCT) imaging.
Change in Canine Inclination in the Coronal View
Time frame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
The mesiodistal inclination of the impacted canine will be calculated which is the angle between the long axis of the impacted canine and the mid-sagittal plane in the coronal view of the cone-beam computed tomography (CBCT) imaging.
Change in the Canine Inclination in the Sagittal View
Time frame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
The labiopalatal inclination of the impacted canine: will be calculated which is the angle between the long axis of the impacted canine and a line perpendicular to the horizontal plane in the sagittal view of the cone-beam computed tomography (CBCT) imaging.
Change in the 3D Canine Location
Time frame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
The vertical distance from the cusp tip of the impacted canine to the upper occlusion plane is measured using the 3D volumetric rendered model of the cone-beam computed tomography (CBCT) imaging.
Relation to adjacent teeth
Time frame: Just one day before the beginning of treatment
The contact between the impacted canine and the central and/or the lateral incisor will be evaluated by looking at the shortest distance between the impacted canine crown and the adjacent incisors' roots This will be done using sequential axial views on the cone-beam computed tomography (CBCT) imaging.
Change in the Absorption to the adjacent roots
Time frame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
Absorption of adjacent roots will be evaluated as follows: In the axial views: an estimation of root damage will be taken into account and will be combined with an estimation of the vertical root damage using 3D volumetric rendered models and then will be classified into one of the four categories Class I: cementum involvement only and located at the apical third of the root Class II: involvement reaching the dentin but vertically less than one-third of the root length. Class III: involvement reaching the dentin and partially the pulp but still vertically less than one-third of the root length. Class IV: involvement reaching the root pulp and damaging more than one third of the root length vertically.

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 9 Feb 2023.
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 25395776Sukh R, Singh GP, Tandon P. Interdisciplinary approach for the management of bilaterally impacted maxillary canines. Contemp Clin Dent. 2014 Oct;5(4):539-44. doi: 10.4103/0976-237X.142828.
Background: PubMed 24963263Shastri D, Nagar A, Tandon P. Alignment of palatally impacted canine with open window technique and modified K-9 spring. Contemp Clin Dent. 2014 Apr;5(2):272-4. doi: 10.4103/0976-237X.132362.
Background: PubMed 18524761Baccetti T, Leonardi M, Armi P. A randomized clinical study of two interceptive approaches to palatally displaced canines. Eur J Orthod. 2008 Aug;30(4):381-5. doi: 10.1093/ejo/cjn023. Epub 2008 Jun 3.
Background: PubMed 15529490Leonardi M, Armi P, Franchi L, Baccetti T. Two interceptive approaches to palatally displaced canines: a prospective longitudinal study. Angle Orthod. 2004 Oct;74(5):581-6. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
Background: PubMed 22105680Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.
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 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 24987661Alqerban A, Jacobs R, van Keirsbilck PJ, Aly M, Swinnen S, Fieuws S, Willems G. The effect of using CBCT in the diagnosis of canine impaction and its impact on the orthodontic treatment outcome. J Orthod Sci. 2014 Apr;3(2):34-40. doi: 10.4103/2278-0203.132911.
Individual participant dataSharing planned: No

Related trials for Impaction of Tooth

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Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
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RecruitingObservational study
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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 Mousa, DDS MSc principal investigator

PhD Student in Orthodontics, University of Damascus Dental School, Damascus

Mohammad Y Hajeer, DDS MSc PhD study director

Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

Omar Heshmeh, DDS MSc PhD study director

Associate Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA

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 withdrawal techniques 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 6 inclusion and 5 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 9 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?

Duration of Canine Traction (time frame: The required time (in days) to achieve complete alignment of the impacted canine will be calculated which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group). The study lists 7 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 NCT03678805, which also lists 9 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 9 Feb 2023.