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Completed

NCT Number: NCT03678805

The Effect of Surgical Interventions to Assist Orthodontic Movement of Impacted Maxillary Canines

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.

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Key information

Conditions

Impaction of Tooth Stomatognathic Diseases Tooth Diseases Tooth, Impacted

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Corticotomy

Procedure

Perforations in the areas close to the impacted canines will be performed in order to accelerate tooth movement.

Traditional withdrawal techniques

Procedure

The impacted canines will be withdrawn using elastic modules.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Sep 20, 2018
Registry last updated
Feb 9, 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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