- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05891665
Evaluation of the Accelerated Traction of Impacted Canines in Terms of Speed and Changes in the Dental Arches
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Damascus, Syrian Arab Republic, DM20AM18
- Department of Orthodontics, University of Damascus Dental School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Patients treated with the acceleration method
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.
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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.
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Active Comparator: Patients treated with the traditional traction technique
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.
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In this group of patients, the traction of the impacted canine will be performed traditionally without the involvement of additional surgical intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Traction time
Time Frame: At the end of the traction stage which is expected to happen within 6 to 8 months
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The interval between the onset of orthodontic traction on the impacted canine and the emergence of half of its clinical crown.
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At the end of the traction stage which is expected to happen within 6 to 8 months
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Total treatment time
Time Frame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
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The time between the bonding of the fixed orthodontic appliance until it is removed.
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At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
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Velocity of the traction movement
Time Frame: At the end of the traction stage which is expected to happen within 6 to 8 months
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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
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At the end of the traction stage which is expected to happen within 6 to 8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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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.
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At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
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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.
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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.
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At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
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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.
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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.
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At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
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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.
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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.
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At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
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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
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Resorption of adjacent lateral root will be evaluated by comparing the root length before and after treatment.
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(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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mahran R. Mousa, DDS MSc, PhD student at the Department of Orthodontics
- Study Chair: Mohammad Y Hajeer, DDS MSc PhD, Professor of Orthodontics, Faculty of Dentistry, University of Damascus
- Study Chair: Omar Heshmeh, DDS MSc PhD, Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, University of Damascus
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDDS-Ortho-10-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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