- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01717417
Three Dimensional Movement Analysis of Maxillary Impacted Canine: a Randomized Clincial Trial
Three Dimensional Movement Analysis of Maxillary Impacted Canine Using TADs: a Randomized Clinical Trial
Maxillary canines are the second-most frequently impacted teeth in the dental arch after the third molars. The suspicion of a maxilary canine impaction raises with the absence of the permanent canine in the arch after the normal period of eruption, and has to be confirmed by a clinical evaluation of the patient and a radiographic assessment.
The approaches to the management of impacted canines are many, but the preferred approach typically involves surgical exposure and guided orthodontic eruption.
The initial mechanical eruption can be achieved in several ways, but an important distinction has to be done according to the anchorage method. The aim of this study is comparing Temporary Anchorage Devices (TADs), and cantilevers with a TMA sectional, using the quantification of canines and molars displacement as the main parameter.
A TAD is a mini screw temporarily fixed to bone for the purpose of enhancing orthodontic anchorage either by supporting the reactive unit (the anchoring tooth) or by obviating the need for it at large, and is subsequently removed after use.
The mini screw employed in this clinical trial will be an alloy type IV titanium screw with 1.5mm diameter and 8-10 mm long, and under local anesthesia will be placed in an area between the first premolar and first molar, on the buccal or labial side according to the canine position and teeth position.
For the evaluation of the canines and molar displacement, two CBCT will be required: the first one before the beginning of the traction (T0), the second one after three months (T1). Both the CBCT will be imported in the MIMICS image processing software (Materialize Group, Leuven, Belgium). Limiting the tissue density ranges and restricting the anatomical area of interest, a cropped colored mask will be obtained from each CBCT. Then the co-registration, through the identification of 5 at least landmark points, will allow the overlap of the two masks. At this point, calculating the 3D surface models, the tooth pre- and post-treatment positions will be evident and the measurement of the displacement possible.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Genoa, Italy, 16100
- Orthodontics Department, Dental School, Genoa University. Italy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- presence of one or two impacted maxillary canine requiring surgical exposure and orthodontic treatment
Exclusion Criteria:
- permanent teeth extraction-based treatment
- current or previous orthodontic treatment in the last 12 months
- current systemic disease
- current antibiotic or antinflammatory therapy that can may compromise the result
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
group 1
Patient treated with Trans Palatal Arch as anchorage for canine traction
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Group 2
Patient treated with miniscrew as anchorage for canine traction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Canine movement
Time Frame: baseline and 3 months after starting treatment
|
Superimposition of two consecutive TC cone beam using at least 5 landmarks point.
Calculation of the 3D surface model and the measureament of the canine and first molar movement
|
baseline and 3 months after starting treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Side effect of traction
Time Frame: baseline and end of treatment
|
Evaluation of Root cervical resorption of other teeth due to canine movement Bone density after three month of traction
|
baseline and end of treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Armando Silvestrini Biavati, MD, DDS, Genoa University, Italy
- Principal Investigator: Marco Migliorati, DDS, MSc, Genoa University, Italy
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MVM1
- GU-1 (Other Identifier: Genoa University)
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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