NCT07294378

Brief Summary

The impaction of maxillary canines is a challenge for orthodontists. Recently, new methods have been proposed to accelerate canine withdrawal. The associated dental changes between the conventional and accelerated methods of canine traction have not yet been assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

December 7, 2025

Last Update Submit

December 20, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in the upper dental midline deviation

    The deviation of the upper dental midline will be measured in millimeters as the distance from the maxillary central incisors contact point to the maxillary model midline. This will be performed on the plaster models.

    T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)

  • Change in the rotation of the lateral incisor.

    The rotation will be measured in degrees as the angle between the maxillary model midline and the line connecting the mesial-distal marginal points of the adjacent lateral incisor.

    T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)

  • Change in the rotation of the first premolar

    The rotation will be measured in degrees as the angle between the maxillary model midline and the line connecting the mesial-distal marginal points of the adjacent first premolar.

    T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)

  • Change in the inter-premolar width

    Inter-premolar width will be measured in millimeters as the distance from the deepest point in the central groove of the adjacent first premolar and its counterpart on the contralateral side

    T1: before the commencement of canine traction (expected to occur within 3-5 months following the beginning of fixed orthodontic treatment). T2: at the end of the canine traction stage (expected to occur with 5-8 months after T1)

Study Arms (2)

Accelerated canine traction group

EXPERIMENTAL

Perforations of the bone surrounding the impacted canine will be conducted at the time of canine exposure. Two months later, another flapless corticotomy procedure will be performed during the withdrawal of the impacted canine.

Procedure: Corticotomy

Conventional canine traction

ACTIVE COMPARATOR

The canines will be withdrawn to the dental arch using the conventionnal method without subjecitng the patient to any additional surgical intervention.

Procedure: Conventional traction

Interventions

CorticotomyPROCEDURE

During the surgical exposure phase in the acceleration group, the cortical bone will be perforated around the exposed canine crown (6-8 holes) wherever possible-this procedure aims to accelerate the withdrawal movement of the impacted canine. A 1 mm round bur will be used to create circular holes (1 mm in diameter, 1-2 mm in depth, and spaced about 1.5 mm apart). After two months of the surgical exposure, the second acceleration procedure will be performed. Two or three vertical incisions (8 mm height) will be made using a surgical scalpel at the buccal side of the impaction area. The cortical cuts (2-3 mm in depth, 1 mm in width, and spaced about 2 mm apart) will be performed using a flapless piezosurgery technique along the vertical lines.

Also known as: flapless corticotomy, piezocision, piezosurgery
Accelerated canine traction group

The canines will be withdrawn using conventional methods without any surgical acceleration.

Conventional canine traction

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients' ages ranged from 18 to 28 years old
  • unilaterally palatally or mid-alveolar upper impacted canine
  • patients who have never received orthodontic treatment previously
  • mild crowding of the maxillary arch (less than 4 mm) and class I first molars relation

You may not qualify if:

  • bilateral or buccal canine impaction
  • patients who have a contraindication to perform oral surgery under local anesthesia (social, psychological, mor edical)
  • more than 45-degree angle between the longitudinal axis of the impacted canines and the facial midline
  • bad oral health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthodontics Department, Faculty of Dentistry

Damascus, Rif-dimashq Governorate, DM20AM19, Syria

Location

Related Publications (5)

  • 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.

    PMID: 17465647BACKGROUND
  • Alyafrusee ES, Zheng B, Almashraqi AA, Almaqrami BS, Yang X, Xu H, Alhammadi MS, Liu Y. Three-dimensional dentoalveolar characteristics of a labially impacted dilacerated maxillary central incisor using cone-beam computed tomography. Sci Rep. 2025 Jul 9;15(1):24669. doi: 10.1038/s41598-025-10043-9.

    PMID: 40634539BACKGROUND
  • Hocevar M, Ovsenik M, Golez A. Position of Maxillary Lateral Incisor and First Premolar in Impaction of Maxillary Canines: A Controlled Clinical CBCT and 3D Study Model Analysis. Dent J (Basel). 2025 Oct 27;13(11):497. doi: 10.3390/dj13110497.

    PMID: 41294478BACKGROUND
  • Mousa MR, Hajeer MY, Burhan AS, Heshmeh O. Adult periodontal comparison after treatment of palatally impacted canines aligned by conventional or accelerated minimally-invasive corticotomy-assisted orthodontic traction: A randomized controlled trial. Int Orthod. 2023 Sep;21(3):100785. doi: 10.1016/j.ortho.2023.100785. Epub 2023 Jun 15.

    PMID: 37329591BACKGROUND
  • Mousa MR, Hajeer MY, Burhan AS, Heshmeh O, Alam MK. The effectiveness of minimally-invasive corticotomy-assisted orthodontic treatment of palatally impacted canines compared to the traditional traction method in terms of treatment duration, velocity of traction movement and the associated dentoalveolar changes: A randomized controlled trial. F1000Res. 2023 Jun 19;12:699. doi: 10.12688/f1000research.135338.1. eCollection 2023.

    PMID: 37920456BACKGROUND

MeSH Terms

Conditions

Tooth, Impacted

Interventions

Piezosurgery

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mahran Raheel Mousa, DDS, MSc, PhD

    Department of Orthodontics, Faculty of Dentistry, Al-Hawash Private University, Homs, Syria

    PRINCIPAL INVESTIGATOR
  • Mohammad Younis Hajeer, DDS, MSc, PhD

    Department of Orthodontics, Faculty of Dentistry, Damascus University

    STUDY DIRECTOR
  • Omar Ahmad Heshmeh, DDS, MSc, PhD

    Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Damascus University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2025

First Posted

December 19, 2025

Study Start

March 2, 2023

Primary Completion

October 15, 2024

Study Completion

January 19, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations