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

Primary Purpose

Impaction of Tooth

Status

Completed

Phase

Not Applicable

Locations

Syrian Arab Republic

Study Type

Interventional

Intervention

Corticotomy

Traditional withdrawal techniques

About this trial

This is an interventional treatment trial for Impaction of Tooth

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Department of Orthodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acceleration

Traditional Traction

Arm Description

The impacted canines will undergo acceleration by corticotomy accompanied with traditional traction techniques.

Traditional traction will be employed in this group of patients with impacted canines. Traditional withdrawal techniques will be used.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03678805

First Posted

September 17, 2018

Last Updated

February 7, 2023

Sponsor

Damascus University

1. Study Identification

Unique Protocol Identification Number

NCT03678805

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

July 2, 2018 (Actual)

Primary Completion Date

June 20, 2021 (Actual)

Study Completion Date

February 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impaction of Tooth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acceleration

Arm Type

Experimental

Arm Description

The impacted canines will undergo acceleration by corticotomy accompanied with traditional traction techniques.

Arm Title

Traditional Traction

Arm Type

Active Comparator

Arm Description

Traditional traction will be employed in this group of patients with impacted canines. Traditional withdrawal techniques will be used.

Intervention Type

Procedure

Intervention Name(s)

Corticotomy

Intervention Description

Perforations in the areas close to the impacted canines will be performed in order to accelerate tooth movement.

Intervention Type

Procedure

Intervention Name(s)

Traditional withdrawal techniques

Intervention Description

The impacted canines will be withdrawn using elastic modules.

Primary Outcome Measure Information:

Title

Duration of Canine Traction

Description

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.

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

Title

Change in Canine Location in the Axial View

Description

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.

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.

Title

Change in Canine Inclination in the Coronal View

Description

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.

Title

Change in the Canine Inclination in the Sagittal View

Description

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.

Title

Change in the 3D Canine Location

Description

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.

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.

Title

Relation to adjacent teeth

Description

Time Frame

Just one day before the beginning of treatment

Title

Change in the Absorption to the adjacent roots

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahran Mousa, DDS MSc

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohammad Y Hajeer, DDS MSc PhD

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Omar Heshmeh, DDS MSc PhD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Department of Orthodontics, University of Damascus Dental School

City

Damascus

ZIP/Postal Code

DM20AM18

Country

Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17465647

Citation

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.

Results Reference

background

PubMed Identifier

25395776

Citation

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.

Results Reference

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PubMed Identifier

24963263

Citation

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.

Results Reference

background

PubMed Identifier

18524761

Citation

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.

Results Reference

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PubMed Identifier

15529490

Citation

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.

Results Reference

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PubMed Identifier

22105680

Citation

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.

Results Reference

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PubMed Identifier

16214621

Citation

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.

Results Reference

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PubMed Identifier

23349422

Citation

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.

Results Reference

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PubMed Identifier

24987661

Citation

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.

Results Reference

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

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