NCT05891665

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

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

January 15, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
Last Updated

June 7, 2023

Status Verified

May 1, 2023

Enrollment Period

2.9 years

First QC Date

May 14, 2023

Last Update Submit

May 26, 2023

Conditions

Keywords

Canine impactionAcceleration of tooth movementCorticotomyMinimally invasive accelerationMaxillary canine impactionWithdrawal of an impacted caninePiezosurgery

Outcome Measures

Primary Outcomes (3)

  • Traction time

    The interval between the onset of orthodontic traction on the impacted canine and the emergence of half of its clinical crown.

    At the end of the traction stage which is expected to happen within 6 to 8 months

  • Total treatment time

    The time between the bonding of the fixed orthodontic appliance until it is removed.

    At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.

  • 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

    At the end of the traction stage which is expected to happen within 6 to 8 months

Secondary Outcomes (5)

  • Bone support ratio of the aligned canine

    At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.

  • Bone support ratio of the contralateral naturally erupting canine

    At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.

  • Bone support ratio of the adjacent lateral incisor

    At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.

  • Bone support ratio of the adjacent first premolar

    At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.

  • Change of the root length of the adjacent lateral incisor

    (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

Study Arms (2)

Patients treated with the acceleration method

EXPERIMENTAL

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.

Procedure: Corticotomy

Patients treated with the traditional traction technique

ACTIVE COMPARATOR

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.

Procedure: Traditional traction of the impacted canine without corticotomy

Interventions

CorticotomyPROCEDURE

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.

Patients treated with the acceleration method

In this group of patients, the traction of the impacted canine will be performed traditionally without the involvement of additional surgical intervention.

Patients treated with the traditional traction technique

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (7)

  • 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.

    PMID: 34688577BACKGROUND
  • 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.

    PMID: 14614417BACKGROUND
  • 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.

    PMID: 6578683BACKGROUND
  • 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.

    PMID: 23349422BACKGROUND
  • 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
  • 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.

    PMID: 35572459BACKGROUND
  • 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.

    PMID: 31056030BACKGROUND

Study Officials

  • Mahran R. Mousa, DDS MSc

    PhD student at the Department of Orthodontics

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY CHAIR

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

May 14, 2023

First Posted

June 7, 2023

Study Start

January 15, 2020

Primary Completion

December 1, 2022

Study Completion

March 12, 2023

Last Updated

June 7, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations