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NCT Number: NCT01717417

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

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Key information

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthodontics Department, Dental School, Genoa University. Italy

Genoa, 16100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

miniscrew

Device

TPA

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Genova

Other

Collaborators

  • University of Michigan

Registry information

Official study title

Three Dimensional Movement Analysis of Maxillary Impacted Canine Using TADs: a Randomized Clinical Trial

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2012
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.