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Comparison Between Two Methods in the Acceleration of the Retraction of Upper Canines

Primary Purpose

Malocclusion, Angle Class II, Division 1

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

About this trial

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

Eligibility Criteria

18 Years - 27 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 15-28 years
  • Patients who have malocclusion class II type I and who require first-premolar extraction with:
  • Dentoalveolar class II type I with ANB between (0-5)
  • Protrusion between (5-10 mm)
  • Overbite between (0-4)
  • Vertical dimension is normal or over the normal range
  • Mild to moderate crowding
  • All patients should have complete permanent occlusion on maxilla

  • All patients should have normal periodontal tissue and good oral health which will be assessed by:

    1. Depth of the gingival pocket does not exceed 4 mm
    2. Plaque index does not exceed 1
    3. Gingival index does not exceed 1

Exclusion Criteria:

  • Patients in which oral surgery under local anesthesia is contraindicated due to medical, psychological, or social reasons.
  • Patients who have a general health problem that affects dental movement
  • Patients who have undergone previous orthodontic treatment
  • Patients with mixed occlusion
  • Patients who have lost one or more from their teeth since birth or who have one of the permanent teeth extracted (except third molar)
  • Patients who have bad oral health or active periodontal disease

Sites / Locations

  • Orthodontic Department, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Cortico-alveolar perforations

Traditional Corticotomy

Control

Arm Description

Patients will undergo orthodontic treatment plus cortico-alveolar perforations.

Patients will undergo orthodontic treatment plus an acceleration procedure employing traditional corticotomy.

Patients will undergo orthodontic treatment in which canine retraction will be accomplished using the standard sliding mechanism without any acceleration procedures.

Outcomes

Primary Outcome Measures

Change in Canine Retraction Speed
The rate at which canine is going to be retracted (mm/month) in each group will be calculated. This outcome will be measured by the following steps: Drawing a projection from the upper canine apex to the middle palatal bone line. Drawing a projection from the mesial ending of the third palatal rugae to the middle palatal bone line. Measuring the distance (mm) between the two orthogonal projections. The rate of canine retraction will be measured by dividing the distance between the two orthogonal projections by the time elapsed between assessment times.
Change in Anchorage Loss
Anchorage loss in related the mesial drift of the first molar. This outcome will be measured by drawing two projections from the central groove of the first maxillary molar and the mesial ending of the third palatal rugae to the middle palatal bone line. The mesial migration of the first maxillary molar (mm) will be measured by dividing the distance between the two projections by the time elapsed between assessment times.
Change in Canine Rotation
The angle between the middle palatal bone and the line through the mesial and distal edges of the canine will be measured on each side. The rotation will be assessed by calculating the difference between the angles on two different times. Then, the speed of rotation will be calculated by dividing the rotation angle (degrees) by time that elapsed between assessment times.
Change in Canine Axis
The changes in the canine axis during retraction will be studied by calculating canine angulation (arithmetic mean of the angulation of the right and left upper canine axis with the anterior cranial base plane) on lateral cephalometric radiographs. The difference between the canine angulation on T1 and T2 will be calculated after comparing the two cephalometric using Viewbox version 4.0.0.98.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2018
Last Updated
March 29, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT03659188
Brief Title
Comparison Between Two Methods in the Acceleration of the Retraction of Upper Canines
Official Title
Evaluation of the Efficiency and Efficacy of Flapless Cortico-alveolar Perforations Using Mechanical Drills Versus Traditional Corticotomy in the Retraction of Upper Canines: a Three-arm Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 2, 2018 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
August 12, 2020 (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
Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched. The aim of this study is to compare flapless bone cutting by mechanical drills to evaluate the acceleration of the retraction of upper canines versus traditional bone cutting by piezo-surgery in comparison with a control group without bone cutting after extraction of upper first premolars in class II type I patients.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cortico-alveolar perforations
Arm Type
Experimental
Arm Description
Patients will undergo orthodontic treatment plus cortico-alveolar perforations.
Arm Title
Traditional Corticotomy
Arm Type
Experimental
Arm Description
Patients will undergo orthodontic treatment plus an acceleration procedure employing traditional corticotomy.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will undergo orthodontic treatment in which canine retraction will be accomplished using the standard sliding mechanism without any acceleration procedures.
Intervention Type
Procedure
Intervention Name(s)
Cortico-alveolar perforations
Other Intervention Name(s)
Flapless corticotomy
Intervention Description
Mechanical drills will be used on a handpiece
Intervention Type
Procedure
Intervention Name(s)
Traditional Corticotomy
Intervention Description
Piezo-surgery will be employed following flaps' elevation.
Primary Outcome Measure Information:
Title
Change in Canine Retraction Speed
Description
The rate at which canine is going to be retracted (mm/month) in each group will be calculated. This outcome will be measured by the following steps: Drawing a projection from the upper canine apex to the middle palatal bone line. Drawing a projection from the mesial ending of the third palatal rugae to the middle palatal bone line. Measuring the distance (mm) between the two orthogonal projections. The rate of canine retraction will be measured by dividing the distance between the two orthogonal projections by the time elapsed between assessment times.
Time Frame
T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months
Title
Change in Anchorage Loss
Description
Anchorage loss in related the mesial drift of the first molar. This outcome will be measured by drawing two projections from the central groove of the first maxillary molar and the mesial ending of the third palatal rugae to the middle palatal bone line. The mesial migration of the first maxillary molar (mm) will be measured by dividing the distance between the two projections by the time elapsed between assessment times.
Time Frame
T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months
Title
Change in Canine Rotation
Description
The angle between the middle palatal bone and the line through the mesial and distal edges of the canine will be measured on each side. The rotation will be assessed by calculating the difference between the angles on two different times. Then, the speed of rotation will be calculated by dividing the rotation angle (degrees) by time that elapsed between assessment times.
Time Frame
T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months
Title
Change in Canine Axis
Description
The changes in the canine axis during retraction will be studied by calculating canine angulation (arithmetic mean of the angulation of the right and left upper canine axis with the anterior cranial base plane) on lateral cephalometric radiographs. The difference between the canine angulation on T1 and T2 will be calculated after comparing the two cephalometric using Viewbox version 4.0.0.98.
Time Frame
T1: at the end of the alignment stage (which is expected within 3 to 4 months); T2: at the end of the canine retraction stage (which is expected to occur with 4 to five months following the onset of this stage).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-27 years Patients who have malocclusion class II type I and who require first-premolar extraction with: Dentoalveolar class II type I with ANB between 5 and 9 degrees. Protrusion between (5-10 mm) Overbite between (0-4) Vertical dimension is normal or over the normal range Mild to moderate crowding All patients should have complete permanent occlusion on the maxilla All patients should have normal periodontal tissue and good oral health, which will be assessed by: Depth of the gingival pocket does not exceed 4 mm Plaque index does not exceed 1 Gingival index does not exceed 1 Exclusion Criteria: Patients in which oral surgery under local anesthesia is contraindicated due to medical, psychological, or social reasons. Patients who have a general health problem that affects dental movement Patients who have undergone previous orthodontic treatment Patients with mixed occlusion Patients who have lost one or more of their teeth since birth or who have one of the permanent teeth extracted (except the third molar) Patients who have bad oral health or active periodontal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Al-Bitar, DDS MSc
Organizational Affiliation
MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bassel Brad, DDS MSc PhD
Organizational Affiliation
Associate Professor of Oral and Maxillofacial Surgery, Oral and Maxillofacial Surgery Department, University of Damascus Dental School, Damascus, SYRIA
Official's Role
Study Director
Facility Information:
Facility Name
Orthodontic Department, 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
27021451
Citation
Abbas NH, Sabet NE, Hassan IT. Evaluation of corticotomy-facilitated orthodontics and piezocision in rapid canine retraction. Am J Orthod Dentofacial Orthop. 2016 Apr;149(4):473-80. doi: 10.1016/j.ajodo.2015.09.029.
Results Reference
background
PubMed Identifier
27696311
Citation
Alfawal AM, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Effectiveness of minimally invasive surgical procedures in the acceleration of tooth movement: a systematic review and meta-analysis. Prog Orthod. 2016 Dec;17(1):33. doi: 10.1186/s40510-016-0146-9. Epub 2016 Oct 24.
Results Reference
background
PubMed Identifier
24182579
Citation
Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
Results Reference
background
PubMed Identifier
25989211
Citation
Aksakalli S, Calik B, Kara B, Ezirganli S. Accelerated tooth movement with piezocision and its periodontal-transversal effects in patients with Class II malocclusion. Angle Orthod. 2016 Jan;86(1):59-65. doi: 10.2319/012215-49.1. Epub 2015 May 19.
Results Reference
background
PubMed Identifier
29436571
Citation
Buyuk SK, Yavuz MC, Genc E, Sunar O. A novel method to accelerate orthodontic tooth movement. Saudi Med J. 2018 Feb;39(2):203-208. doi: 10.15537/smj.2018.2.21235.
Results Reference
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Comparison Between Two Methods in the Acceleration of the Retraction of Upper Canines

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