- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04887974
Canine Retraction With Temporary Anchorage Devices
Canine Retraction Using Power Arms and Temporary Anchorage Devices
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Faculty of Oral & Dental Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Canine retraction
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Canine retraction
Time Frame: Baseline to 6 months
|
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
|
Baseline to 6 months
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Molar mesial drift
Time Frame: Baseline to 6 months
|
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
|
Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Canine tipping
Time Frame: Baseline to 6 months
|
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.
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Baseline to 6 months
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molar rotation
Time Frame: Baseline to 6 months
|
The change in the angle between the molar horizontal axis and frontal Plane on the cone beam computed tomogram, in the axial view.
|
Baseline to 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yehya Mostafa, Future University in Egypt
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Tooth Diseases
- Stomatognathic System Abnormalities
- Jaw Abnormalities
- Jaw Diseases
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Mandibular Diseases
- Malocclusion
- Malocclusion, Angle Class II
- Overbite
- Prognathism
- Malocclusion, Angle Class III
Other Study ID Numbers
- 20153110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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