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

Sponsor
Damascus University (Other)
Overall Status
Completed
CT.gov ID
NCT05891665
Collaborator
(none)
46
1
2
37.8
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Corticotomy
  • Procedure: Traditional traction of the impacted canine without corticotomy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official 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.
Actual Study Start Date :
Jan 15, 2020
Actual Primary Completion Date :
Dec 1, 2022
Actual Study Completion Date :
Mar 12, 2023

Arms and Interventions

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.

Procedure: Corticotomy
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.

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

Outcome Measures

Primary Outcome Measures

  1. Traction time [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 [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 [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 Outcome Measures

  1. Bone support ratio of the aligned canine [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 [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 [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 [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 [(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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 28 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Orthodontics, University of Damascus Dental School Damascus Syrian Arab Republic DM20AM18

Sponsors and Collaborators

  • Damascus University

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Damascus University
ClinicalTrials.gov Identifier:
NCT05891665
Other Study ID Numbers:
  • UDDS-Ortho-10-2023
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 7, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Damascus University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2023