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Canine Retraction With Temporary Anchorage Devices

Primary Purpose

Class II Malocclusion, Class III Malocclusion, Crowding, Tooth

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
canine retraction
Sponsored by
Future University in Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Malocclusion

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult orthodontic patient
  • Any malocclusion requiring the extraction of the first premolar and canine retraction
  • Full permanent dentition with the exception of the wisdom teeth.

Exclusion Criteria:

  • Any missing permanent tooth
  • Previous orthodontic treatment
  • Periodontal disease; pregnancy
  • Systemic disease or medication that affects bone metabolism

Sites / Locations

  • Faculty of Oral & Dental Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Canine retraction

Arm Description

The canines will be retracted by extending short silver elastomeric chains between the power arms in the canine brackets and the TADs. The applied force will be checked and adjusted to 150 g.

Outcomes

Primary Outcome Measures

Canine retraction
Amount of canine movement in millimeters measured on digital models. . The change in the vertical distance from the canine cusp tip to a line connecting the medial points of the third palatal rugae
Molar mesial drift
Amount of molar movement in millimeters measured on digital models. The change in the vertical distance from the mesiobuccal cusp tip to a line connecting the medial points of the third palatal rugae

Secondary Outcome Measures

Canine tipping
The change in the angle between the canine long axis, from cusp tip to root apex, and the palatal plane (a plane passing through the incisive foramen and the anterior and posterior nasal spines); measued on the cone beam computed tomogram.
molar rotation
The change in the angle between the molar horizontal axis and frontal Plane on the cone beam computed tomogram, in the axial view.

Full Information

First Posted
May 7, 2021
Last Updated
May 12, 2021
Sponsor
Future University in Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04887974
Brief Title
Canine Retraction With Temporary Anchorage Devices
Official Title
Canine Retraction Using Power Arms and Temporary Anchorage Devices
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 2, 2016 (Actual)
Primary Completion Date
January 14, 2017 (Actual)
Study Completion Date
January 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Future University in Egypt

4. Oversight

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

5. Study Description

Brief Summary
Various malocclusions require the extraction of the first premolars and retraction of the canines with the need for maximum anchorage. If the canines are pulled into the extraction space using the molar teeth for support, unwanted tooth movement occurs. This study aims to evaluate the effect of temporary anchorage devices and power arms, which are auxiliary orthodontic appliances in reducing undesirable tooth movements.
Detailed Description
In orthodontic patients who require overjet correction, increased facial convexity, or relief of severe crowding, dental extraction followed by canine retraction is indicated. In conventional orthodontic treatment, the molars are used for anchorage and reinforced with intra-oral or extra-oral appliances. Although effective, this produces unwanted side effects where the molars move mesially and rotate, taking up some of the extraction space. As the canines move into the extraction space they tip backward requiring further uprighting. Power arms are vertical metal extensions placed in the canine brackets. They direct the force to the center of resistance of the tooth to allow bodily movement and prevent canine tipping. Temporary anchorage devices (TADs) are minimally invasive, small screws, inserted in the jaw bones to act as anchorage units instead of the molars. This study aims to evaluate the effect of the TADs and power arms on the efficiency of canine retraction including the rate of canine retraction and canine tipping as well as mesial molar drift and rotation. The null hypothesis is that the use of the power arm and the TADs have no effect on the canine retraction rate. This study is a single-arm, single-center study. Twenty quadrants in 10 adult patients will be selected from the Orthodontic Outpatient Clinic at the Future University in Egypt. Orthodontic records will be collected including study models, intra- and extra-oral photographs and cone beam computed tomograms. Molars will be banded and Roth 0.22" brackets will be bonded to the canine and second premolars. Power arms, 8mmin length, will be inserted in the vertical slots of the canine brackets. The dental arches will be leveled and aligned using consecutive archwires. TADs will be inserted between the second premolars and first molars. The first premolars will then be extracted and canines will be retracted within a week. Canines will be retracted along 0.016" X 0.22" stainless steel archwires using 150 g of force applied by an elastomeric chain. The elastic chain will be replaced every 4 weeks. After 6 months of canine retraction, the orthodontic records will be collected for comparison.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion, Class III Malocclusion, Crowding, Tooth, Bimaxillary Protrusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canine retraction
Arm Type
Experimental
Arm Description
The canines will be retracted by extending short silver elastomeric chains between the power arms in the canine brackets and the TADs. The applied force will be checked and adjusted to 150 g.
Intervention Type
Procedure
Intervention Name(s)
canine retraction
Intervention Description
Canine retraction using elastomeric chains activated every 4 weeks, using power arms to direct force through the center of resistance and TADs for direct anchorage.
Primary Outcome Measure Information:
Title
Canine retraction
Description
Amount of canine movement in millimeters measured on digital models. . The change in the vertical distance from the canine cusp tip to a line connecting the medial points of the third palatal rugae
Time Frame
Baseline to 6 months
Title
Molar mesial drift
Description
Amount of molar movement in millimeters measured on digital models. The change in the vertical distance from the mesiobuccal cusp tip to a line connecting the medial points of the third palatal rugae
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Canine tipping
Description
The change in the angle between the canine long axis, from cusp tip to root apex, and the palatal plane (a plane passing through the incisive foramen and the anterior and posterior nasal spines); measued on the cone beam computed tomogram.
Time Frame
Baseline to 6 months
Title
molar rotation
Description
The change in the angle between the molar horizontal axis and frontal Plane on the cone beam computed tomogram, in the axial view.
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult orthodontic patient Any malocclusion requiring the extraction of the first premolar and canine retraction Full permanent dentition with the exception of the wisdom teeth. Exclusion Criteria: Any missing permanent tooth Previous orthodontic treatment Periodontal disease; pregnancy Systemic disease or medication that affects bone metabolism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehya Mostafa
Organizational Affiliation
Future University in Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Oral & Dental Medicine
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Canine Retraction With Temporary Anchorage Devices

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