NCT03149016

Brief Summary

We aim to assess the treatment outcomes following upper incisors retraction accelerated by corticotomy procedure. So, we intend to randomize orthodontic patients with class II division I malocclusion into two groups: experimental group and control group. Both groups will start orthodontic treatment. Once a 0.019\*0.025-inch stainless steel wire is fully engaged to the brackets, 1st premolars will be extracted. Canines will be retracted in the conventional manner. Then, the actual evaluation period starts when the upper incisors are retracted using two different methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

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

August 20, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2018

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

May 9, 2017

Last Update Submit

July 27, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Rate of retraction

    The distance that the incisors moved during retraction divided by the time required to retract the four upper incisors to their ideal positions.

    This will be measured at the completion of the retraction procedure, and is expected to take 2 months in the experimental group and four months in the control group.

  • Time required for retraction

    The time required from the beginning of incisors' retraction till the the completion of this procedure.

    This will be measured at the completion of the retraction procedure, and is expected to be within 2 months in the accelerated group and 4 months in the control group.

Secondary Outcomes (3)

  • Change in the axial inclination of upper incisors

    A radiograph will be taken at T1: one day before upper incisors' retraction and T2: one day after the completion of upper incisors' retraction. Completion of upper incisors' retraction is expected to be within 2 months in the accelerated group and 4 mo

  • Anchorage loss

    This will be measured one day following the completion of retraction of the upper four incisors using plaster study models and is expected to be within 2 months in the accelerated group and 4 months in the control group

  • Root resorption

    An panoramic image will be taken at T1: one day before the commencement of incisor retraction and T2: one day following the completion of retraction and is expected to be within 2 months in the accelerated group and 4 months in the control group

Study Arms (2)

Corticotomy-assisted Retraction

EXPERIMENTAL

Corticotomy-assisted retraction will be performed in order to help in accelerating upper incisors' retraction

Procedure: Corticotomy-assisted Retraction

Conventional Retraction

NO INTERVENTION

Conventional retraction will be used in this group of patients by sliding mechanisms

Interventions

Using a tunneling technique, the researcher will perform the intervention in the alveolar bone surrounding the upper incisors before retraction.

Corticotomy-assisted Retraction

Eligibility Criteria

Age15 Years - 27 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adult patients 15 to 27 years , with permanent dentition , without hypodontia .
  • Overjet less than 10 mm
  • Normal or increased growth pattern (Diagnosed by Y-axis angle)
  • Mild to moderate crowding (Less than 3 mm)
  • After canines retraction , at least 3 mm space should be available distal the lateral incisors
  • Midline deviation shouldn't be more than 3 mm

You may not qualify if:

  • Medically contraindicated patients to oral surgery .
  • Existence of general health issue that affect orthodontic teeth movement
  • Previous orthodontic treatment
  • Mixed dentition
  • Hypodontia (Except third molars)
  • Bad oral hygiene

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 (7)

  • Aboul-Ela SM, El-Beialy AR, El-Sayed KM, Selim EM, El-Mangoury NH, Mostafa YA. Miniscrew implant-supported maxillary canine retraction with and without corticotomy-facilitated orthodontics. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):252-9. doi: 10.1016/j.ajodo.2009.04.028.

    PMID: 21300255BACKGROUND
  • Al-Naoum F, Hajeer MY, Al-Jundi A. Does alveolar corticotomy accelerate orthodontic tooth movement when retracting upper canines? A split-mouth design randomized controlled trial. J Oral Maxillofac Surg. 2014 Oct;72(10):1880-9. doi: 10.1016/j.joms.2014.05.003. Epub 2014 May 14.

    PMID: 25128922BACKGROUND
  • Choo H, Heo HA, Yoon HJ, Chung KR, Kim SH. Treatment outcome analysis of speedy surgical orthodontics for adults with maxillary protrusion. Am J Orthod Dentofacial Orthop. 2011 Dec;140(6):e251-62. doi: 10.1016/j.ajodo.2011.06.029.

    PMID: 22133959BACKGROUND
  • Chung KR, Kim SH, Lee BS. Speedy surgical-orthodontic treatment with temporary anchorage devices as an alternative to orthognathic surgery. Am J Orthod Dentofacial Orthop. 2009 Jun;135(6):787-98. doi: 10.1016/j.ajodo.2007.03.036.

    PMID: 19524840BACKGROUND
  • Bhattacharya P, Bhattacharya H, Anjum A, Bhandari R, Agarwal DK, Gupta A, Ansar J. Assessment of Corticotomy Facilitated Tooth Movement and Changes in Alveolar Bone Thickness - A CT Scan Study. J Clin Diagn Res. 2014 Oct;8(10):ZC26-30. doi: 10.7860/JCDR/2014/9448.4954. Epub 2014 Oct 20.

    PMID: 25478442BACKGROUND
  • Dincer M, Gulsen A, Turk T. The retraction of upper incisors with the PG retraction system. Eur J Orthod. 2000 Feb;22(1):33-41. doi: 10.1093/ejo/22.1.33.

    PMID: 10721243BACKGROUND
  • KOLE H. Surgical operations on the alveolar ridge to correct occlusal abnormalities. Oral Surg Oral Med Oral Pathol. 1959 May;12(5):515-29 concl. doi: 10.1016/0030-4220(59)90153-7. No abstract available.

    PMID: 13644913BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Ghaith Al Imam, DDS

    MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria

    PRINCIPAL INVESTIGATOR

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

May 9, 2017

First Posted

May 11, 2017

Study Start

August 20, 2016

Primary Completion

January 20, 2018

Study Completion

April 15, 2018

Last Updated

July 30, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations