NCT03678805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

September 17, 2018

Last Update Submit

February 7, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Duration of Canine Traction

    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.

    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

  • Change in Canine Location in the Axial View

    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.

    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.

  • Change in Canine Inclination in the Coronal View

    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.

    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.

  • Change in the Canine Inclination in the Sagittal View

    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.

    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.

  • Change in the 3D Canine Location

    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.

    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.

  • Relation to adjacent teeth

    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.

    Just one day before the beginning of treatment

  • Change in the Absorption to the adjacent roots

    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.

    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.

Study Arms (2)

Acceleration

EXPERIMENTAL

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

Procedure: Corticotomy

Traditional Traction

ACTIVE COMPARATOR

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

Procedure: Traditional withdrawal techniques

Interventions

CorticotomyPROCEDURE

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

Acceleration

The impacted canines will be withdrawn using elastic modules.

Traditional Traction

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (9)

  • Fischer TJ. Orthodontic treatment acceleration with corticotomy-assisted exposure of palatally impacted canines. Angle Orthod. 2007 May;77(3):417-20. doi: 10.2319/0003-3219(2007)077[0417:OTAWCE]2.0.CO;2.

    PMID: 17465647BACKGROUND
  • Sukh R, Singh GP, Tandon P. Interdisciplinary approach for the management of bilaterally impacted maxillary canines. Contemp Clin Dent. 2014 Oct;5(4):539-44. doi: 10.4103/0976-237X.142828.

    PMID: 25395776BACKGROUND
  • Shastri D, Nagar A, Tandon P. Alignment of palatally impacted canine with open window technique and modified K-9 spring. Contemp Clin Dent. 2014 Apr;5(2):272-4. doi: 10.4103/0976-237X.132362.

    PMID: 24963263BACKGROUND
  • Baccetti T, Leonardi M, Armi P. A randomized clinical study of two interceptive approaches to palatally displaced canines. Eur J Orthod. 2008 Aug;30(4):381-5. doi: 10.1093/ejo/cjn023. Epub 2008 Jun 3.

    PMID: 18524761BACKGROUND
  • Leonardi M, Armi P, Franchi L, Baccetti T. Two interceptive approaches to palatally displaced canines: a prospective longitudinal study. Angle Orthod. 2004 Oct;74(5):581-6. doi: 10.1043/0003-3219(2004)0742.0.CO;2.

    PMID: 15529490BACKGROUND
  • Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.

    PMID: 22105680BACKGROUND
  • Walker L, Enciso R, Mah J. Three-dimensional localization of maxillary canines with cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2005 Oct;128(4):418-23. doi: 10.1016/j.ajodo.2004.04.033.

    PMID: 16214621BACKGROUND
  • Smailiene D, Kavaliauskiene A, Pacauskiene I, Zasciurinskiene E, Bjerklin K. Palatally impacted maxillary canines: choice of surgical-orthodontic treatment method does not influence post-treatment periodontal status. A controlled prospective study. Eur J Orthod. 2013 Dec;35(6):803-10. doi: 10.1093/ejo/cjs102. Epub 2013 Jan 24.

    PMID: 23349422BACKGROUND
  • Alqerban A, Jacobs R, van Keirsbilck PJ, Aly M, Swinnen S, Fieuws S, Willems G. The effect of using CBCT in the diagnosis of canine impaction and its impact on the orthodontic treatment outcome. J Orthod Sci. 2014 Apr;3(2):34-40. doi: 10.4103/2278-0203.132911.

    PMID: 24987661BACKGROUND

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Mahran Mousa, DDS MSc

    PhD Student in Orthodontics, University of Damascus Dental School, Damascus

    PRINCIPAL INVESTIGATOR
  • Mohammad Y Hajeer, DDS MSc PhD

    Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

    STUDY DIRECTOR
  • Omar Heshmeh, DDS MSc PhD

    Associate Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 20, 2018

Study Start

July 2, 2018

Primary Completion

June 20, 2021

Study Completion

February 5, 2023

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations