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Clinical Trials/NCT05891665
NCT05891665CompletedNot Applicable

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.

Damascus University1 site in 1 country46 target enrollmentStarted: January 15, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
46
Locations
1
Primary Endpoint
Total treatment time

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 28 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients aged 18 to
  • •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.

Arms & Interventions

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.

Intervention: Corticotomy (Procedure)

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.

Intervention: Traditional traction of the impacted canine without corticotomy (Procedure)

Outcomes

Primary Outcomes

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.

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

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.

Secondary Outcomes

  • 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)
  • 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 first premolar(At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.)
  • 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 adjacent lateral incisor(At the end of the orthodontic treatment which is expected to happen between 15 to 24 months.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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