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The Use of Corticotomy for Upper Incisors Retraction

Primary Purpose

Class II Division 1 Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Corticotomy-assisted Retraction
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Division 1 Malocclusion

Eligibility Criteria

15 Years - 27 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Orthodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Corticotomy-assisted Retraction

Conventional Retraction

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in the axial inclination of upper incisors
the angle between the long axis of the upper incisor and a reference plane drawn on a later cephalometric radiograph teken at two assessment times.
Anchorage loss
the amount of anchorage loss (in mm), which is the distance from a perpendicular line to the midpalatal suture and extends between central fossa of both upper first molars to the third palatal rugae . These measurements are made on plaster study models.
Root resorption
This variable is related to the amount of incisor root resorption after treatment in both groups. This is measured on a panoramic image. The amount of root resorption = the length of an incisor after retraction subtracted from the length of an incisor before retraction. Two radiogrpahs are needed.

Full Information

First Posted
May 9, 2017
Last Updated
July 27, 2018
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT03149016
Brief Title
The Use of Corticotomy for Upper Incisors Retraction
Official Title
Evaluation of Treatment Outcomes of Corticotomy-accelerated Upper Incisors' Retraction: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 20, 2016 (Actual)
Primary Completion Date
January 20, 2018 (Actual)
Study Completion Date
April 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In the last three decades, the number of adult patients seeking short orthodontic treatment time has apparently increased as the conventional orthodontic treatment usually lasts for 20-24 months. Furthermore, orthodontic treatment is often associated with root resorption, bone degradation and caries development. Patients nowadays desire to end the orthodontic treatment as soon as possible due to phsycosocial reasons and to get the goals of the treatment without affecting their social life . So many tooth movement accelerating methods have been proposed. However, the surgical approached are considered the most effective and promising methods in accelerating tooth movement. The current research aims to evaluate the efficacy of the a new proposed surgical method compared to the conventional method in upper incisors' retraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corticotomy-assisted Retraction
Arm Type
Experimental
Arm Description
Corticotomy-assisted retraction will be performed in order to help in accelerating upper incisors' retraction
Arm Title
Conventional Retraction
Arm Type
No Intervention
Arm Description
Conventional retraction will be used in this group of patients by sliding mechanisms
Intervention Type
Procedure
Intervention Name(s)
Corticotomy-assisted Retraction
Intervention Description
Using a tunneling technique, the researcher will perform the intervention in the alveolar bone surrounding the upper incisors before retraction.
Primary Outcome Measure Information:
Title
Rate of retraction
Description
The distance that the incisors moved during retraction divided by the time required to retract the four upper incisors to their ideal positions.
Time Frame
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.
Title
Time required for retraction
Description
The time required from the beginning of incisors' retraction till the the completion of this procedure.
Time Frame
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 Outcome Measure Information:
Title
Change in the axial inclination of upper incisors
Description
the angle between the long axis of the upper incisor and a reference plane drawn on a later cephalometric radiograph teken at two assessment times.
Time Frame
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
Title
Anchorage loss
Description
the amount of anchorage loss (in mm), which is the distance from a perpendicular line to the midpalatal suture and extends between central fossa of both upper first molars to the third palatal rugae . These measurements are made on plaster study models.
Time Frame
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
Title
Root resorption
Description
This variable is related to the amount of incisor root resorption after treatment in both groups. This is measured on a panoramic image. The amount of root resorption = the length of an incisor after retraction subtracted from the length of an incisor before retraction. Two radiogrpahs are needed.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghaith Al Imam, DDS
Organizational Affiliation
MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthodontics, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21300255
Citation
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.
Results Reference
background
PubMed Identifier
25128922
Citation
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.
Results Reference
background
PubMed Identifier
22133959
Citation
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.
Results Reference
background
PubMed Identifier
19524840
Citation
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.
Results Reference
background
PubMed Identifier
25478442
Citation
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.
Results Reference
background
PubMed Identifier
10721243
Citation
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.
Results Reference
background
PubMed Identifier
13644913
Citation
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.
Results Reference
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The Use of Corticotomy for Upper Incisors Retraction

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