Clinical trial NCT05891665: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 to 28.
2. Unilateral palatally or mid-alveolar upper impacted canine.
3. The impacted canine crown not exceeding the middle of the lateral incisor root.
4. Absence of root resorption of the lateral incisors.
5. No contact between the canine crown and the lateral incisor root.
6. Individuals not previously receiving orthodontic treatment.
7. No use of any medications that may affect the orthodontic movement.

Exclusion Criteria:

1. Bilateral or buccal canine impaction cases.
2. More than 45-degree angle between the canine's longitudinal axis and the vertical facial plane.
3. Any medical condition that prevents oral surgery.
4. Oral structural abnormality that is inherited or congenital.

Primary outcomes:
measure: Traction time
timeFrame: At the end of the traction stage which is expected to happen within 6 to 8 months
measure: Total treatment time
timeFrame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
measure: Velocity of the traction movement
timeFrame: At the end of the traction stage which is expected to happen within 6 to 8 months
Secondary outcomes:
measure: Bone support ratio of the aligned canine
timeFrame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
measure: Bone support ratio of the contralateral naturally erupting canine
timeFrame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
measure: Bone support ratio of the adjacent lateral incisor
timeFrame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
measure: Bone support ratio of the adjacent first premolar
timeFrame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
measure: Change of the root length of the adjacent lateral incisor
timeFrame: (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
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, University of Damascus Dental School
Study officials:
affiliation: PhD student at the Department of Orthodontics
name: Mahran R. Mousa, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Orthodontics, Faculty of Dentistry, University of Damascus
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_CHAIR
affiliation: Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, University of Damascus
name: Omar Heshmeh, DDS MSc PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.