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Evaluation of the Accelerated Traction of Impacted Canines in Terms of Speed and Changes in the Dental Arches

Primary Purpose

Impacted Tooth With Abnormal Positioning

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Corticotomy
Traditional traction of the impacted canine without corticotomy
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Tooth With Abnormal Positioning focused on measuring Canine impaction, Acceleration of tooth movement, Corticotomy, Minimally invasive acceleration, Maxillary canine impaction, Withdrawal of an impacted canine, Piezosurgery

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

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

Patients treated with the acceleration method

Patients treated with the traditional traction technique

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Traction time
The interval between the onset of orthodontic traction on the impacted canine and the emergence of half of its clinical crown.
Total treatment time
The time between the bonding of the fixed orthodontic appliance until it is removed.
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

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
May 14, 2023
Last Updated
May 26, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05891665
Brief Title
Evaluation of the Accelerated Traction of Impacted Canines in Terms of Speed and Changes in the Dental Arches
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
March 12, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients treated with the acceleration method
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients treated with the traditional traction technique
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Corticotomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Traditional traction of the impacted canine without corticotomy
Intervention Description
In this group of patients, the traction of the impacted canine will be performed traditionally without the involvement of additional surgical intervention.
Primary Outcome Measure Information:
Title
Traction time
Description
The interval between the onset of orthodontic traction on the impacted canine and the emergence of half of its clinical crown.
Time Frame
At the end of the traction stage which is expected to happen within 6 to 8 months
Title
Total treatment time
Description
The time between the bonding of the fixed orthodontic appliance until it is removed.
Time Frame
At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Title
Velocity of the traction movement
Description
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
Time Frame
At the end of the traction stage which is expected to happen within 6 to 8 months
Secondary Outcome Measure Information:
Title
Bone support ratio of the aligned canine
Description
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.
Time Frame
At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Title
Bone support ratio of the contralateral naturally erupting canine
Description
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.
Time Frame
At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Title
Bone support ratio of the adjacent lateral incisor
Description
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.
Time Frame
At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Title
Bone support ratio of the adjacent first premolar
Description
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.
Time Frame
At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
Title
Change of the root length of the adjacent lateral incisor
Description
Resorption of adjacent lateral root will be evaluated by comparing the root length before and after treatment.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahran R. Mousa, DDS MSc
Organizational Affiliation
PhD student at the Department of Orthodontics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Professor of Orthodontics, Faculty of Dentistry, University of Damascus
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Omar Heshmeh, DDS MSc PhD
Organizational Affiliation
Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, University of Damascus
Official's Role
Study Chair
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
No
Citations:
PubMed Identifier
34688577
Citation
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.
Results Reference
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PubMed Identifier
14614417
Citation
Becker 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.
Results Reference
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PubMed Identifier
6578683
Citation
Becker 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.
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
background
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
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PubMed Identifier
35572459
Citation
Mousa 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.
Results Reference
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PubMed Identifier
31056030
Citation
Parkin 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.
Results Reference
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Evaluation of the Accelerated Traction of Impacted Canines in Terms of Speed and Changes in the Dental Arches

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