The Effect of Surgical Interventions to Assist Orthodontic Movement of Impacted Maxillary Canines

February 7, 2023 updated by: Damascus University

Evaluation of the Efficiency of Minimally-invasive Surgically-assisted Withdrawal of Palatally Impacted Maxillary Canines in Terms of Movement Velocity and Dento-alveolar Changes: A Randomized Controlled Clinical Trial

Impacted canine causes many problems for patients, such as absorption and damages to the adjacent teeth roots, as well as aesthetic problems. Correction of this problem requires a lengthy time. Therefore, many methods have been suggested to accelerate the movement of impacted canines with the help of surgical procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Orthodontics, University of Damascus Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 30 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Palatal or Mid-alveolar impacted canine.
  2. There is no previous orthodontic treatment.
  3. Healthy periodontal tissues and good oral health (i.e., Plaque Index is less or equal to 1 according to Loe and Silness(1963)).
  4. No consumption of any drug that may interfere with the tooth movement (Cortisone, NSAIDs, …).
  5. Mild or no crowding in the upper jaw.
  6. No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion Criteria:

  1. Any systemic diseases that would affect tooth movement
  2. Antidepressant prevents oral surgery
  3. Any congenital syndromes or cleft lip and palate cases
  4. Bad oral health
  5. Previous orthodontic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Acceleration
The impacted canines will undergo acceleration by corticotomy accompanied with traditional traction techniques.
Procedure: Corticotomy
Perforations in the areas close to the impacted canines will be performed in order to accelerate tooth movement.
ACTIVE_COMPARATOR: Traditional Traction

Traditional traction will be employed in this group of patients with impacted canines.

Traditional withdrawal techniques will be used.
Procedure: Traditional withdrawal techniques
The impacted canines will be withdrawn using elastic modules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Canine Traction
Time Frame: The required time (in days) to achieve complete alignment of the impacted canine will be calculated which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group
The time required in days will be calculated from the beginning of canine traction till the end of canine alignment in its place in the dental arch.
The required time (in days) to achieve complete alignment of the impacted canine will be calculated which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group
Change in Canine Location in the Axial View
Time Frame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
The distance between the cusp tip of the impacted canine to the palatal mid-line in the axial view using cone-beam computed tomography (CBCT) imaging.
T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
Change in Canine Inclination in the Coronal View
Time Frame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
The mesiodistal inclination of the impacted canine will be calculated which is the angle between the long axis of the impacted canine and the mid-sagittal plane in the coronal view of the cone-beam computed tomography (CBCT) imaging.
T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
Change in the Canine Inclination in the Sagittal View
Time Frame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
The labiopalatal inclination of the impacted canine: will be calculated which is the angle between the long axis of the impacted canine and a line perpendicular to the horizontal plane in the sagittal view of the cone-beam computed tomography (CBCT) imaging.
T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
Change in the 3D Canine Location
Time Frame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
The vertical distance from the cusp tip of the impacted canine to the upper occlusion plane is measured using the 3D volumetric rendered model of the cone-beam computed tomography (CBCT) imaging.
T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.
Relation to adjacent teeth
Time Frame: Just one day before the beginning of treatment
The contact between the impacted canine and the central and/or the lateral incisor will be evaluated by looking at the shortest distance between the impacted canine crown and the adjacent incisors' roots This will be done using sequential axial views on the cone-beam computed tomography (CBCT) imaging.
Just one day before the beginning of treatment
Change in the Absorption to the adjacent roots
Time Frame: T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.

Absorption of adjacent roots will be evaluated as follows:

In the axial views: an estimation of root damage will be taken into account and will be combined with an estimation of the vertical root damage using 3D volumetric rendered models and then will be classified into one of the four categories Class I: cementum involvement only and located at the apical third of the root Class II: involvement reaching the dentin but vertically less than one-third of the root length.

Class III: involvement reaching the dentin and partially the pulp but still vertically less than one-third of the root length.

Class IV: involvement reaching the root pulp and damaging more than one third of the root length vertically.
T1: one day before the beginning of treatment; T2: at the end of the traction stage which is expected to occur within 10-12 months in the traditional group and 7-8 months in the accelerated group.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 2, 2018

Primary Completion (ACTUAL)

June 20, 2021

Study Completion (ACTUAL)

February 5, 2023

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (ACTUAL)

September 20, 2018

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Ortho-19 -2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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