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

April 14, 2019 updated by: Marco Migliorati, University of Genova

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

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Genoa, Italy, 16100
        • Orthodontics Department, Dental School, Genoa University. Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred to the Orthodontic Department, Genoa University.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Group 2
Patient treated with miniscrew as anchorage for canine traction

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 14, 2019

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

October 26, 2012

First Posted (Estimate)

October 30, 2012

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 14, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

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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