Evaluation of the Accelerated Traction of Impacted Canines in Terms of Speed and Changes in the Dental Arches

May 26, 2023 updated by: Damascus University

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.

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.

Study Overview

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

Interventional

Enrollment (Actual)

46

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

      • 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

  • Adult

Accepts Healthy Volunteers

No

Description

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.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
In this group of patients, the traction of the impacted canine will be performed traditionally without the involvement of additional surgical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Traction time
Time Frame: At the end of the traction stage which is expected to happen within 6 to 8 months
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
Time Frame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
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
Time Frame: At the end of the traction stage which is expected to happen within 6 to 8 months
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 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.
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.
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
Time Frame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
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.
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
Time Frame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
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.
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
Time Frame: At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.
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.
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
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
Resorption of adjacent lateral root will be evaluated by comparing the root length before and after treatment.
(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

Collaborators and Investigators

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

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

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)

January 15, 2020

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

March 12, 2023

Study Registration Dates

First Submitted

May 14, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

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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