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Completed

NCT Number: NCT05891665

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

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.

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Key information

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Corticotomy

Procedure

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.

Traditional traction of the impacted canine without corticotomy

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 7, 2023
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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