Three Dimensional Movement Analysis of Maxillary Impacted Canine: a Randomized Clincial Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01717417
Recruitment Status : Unknown
Verified December 2013 by Marco Migliorati, University of Genova.
Recruitment status was:  Recruiting
First Posted : October 30, 2012
Last Update Posted : December 11, 2013
University of Michigan
Information provided by (Responsible Party):
Marco Migliorati, University of Genova

Brief Summary:

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.

Condition or disease
Complicated Impacted Tooth

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Three Dimensional Movement Analysis of Maxillary Impacted Canine Using TADs: a Randomized Clinical Trial
Study Start Date : September 2011
Estimated Primary Completion Date : December 2013

Primary Outcome Measures :
  1. Canine and first molar movement
    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

Secondary Outcome Measures :
  1. Side effect of traction

    Evaluation of soft tissue health with clinical evaluation (bleeding on probing, gingival index, plaque index).

    Root cervical resorption of other teeth due to canine movement Bone quality after three month of traction

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to the Orthodontic Department, Genoa University.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01717417

Orthodontics Department, Dental School, Genoa University. Italy Recruiting
Genoa, Italy, 16100
Contact: Marco Migliorati, Doctor    00393383825781   
Sponsors and Collaborators
University of Genova
University of Michigan
Study Director: Armando Silvestrini Biavati, MD, DDS Genoa University, Italy
Principal Investigator: Marco Migliorati, DDS, MSc Genoa University, Italy

Responsible Party: Marco Migliorati, Doctor, University of Genova Identifier: NCT01717417     History of Changes
Other Study ID Numbers: MVM1
GU-1 ( Other Identifier: Genoa University )
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by Marco Migliorati, University of Genova:
impacted canine
cone beam

Additional relevant MeSH terms:
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases