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Clinical Trials/NCT03678805
NCT03678805CompletedNot Applicable

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

Damascus University1 site in 1 country60 target enrollmentStarted: July 2, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Duration of Canine Traction

Study Overview

Brief Summary

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 Design

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

Eligibility Criteria

Ages
15 Years to 30 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Any systemic diseases that would affect tooth movement
  • •Antidepressant prevents oral surgery
  • •Any congenital syndromes or cleft lip and palate cases
  • •Bad oral health
  • •Previous orthodontic treatment

Arms & Interventions

Acceleration

Experimental

The impacted canines will undergo acceleration by corticotomy accompanied with traditional traction techniques.

Intervention: Corticotomy (Procedure)

Traditional Traction

Active Comparator

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

Traditional withdrawal techniques will be used.

Intervention: Traditional withdrawal techniques (Procedure)

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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