Clinical trial NCT01717417: Three Dimensional Movement Analysis of Maxillary Impacted Canine: a Randomized Clincial Trial
Official title: Three Dimensional Movement Analysis of Maxillary Impacted Canine Using TADs: a Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complicated Impacted Tooth
Keywords: impacted canine
miniscrew
cone beam
Lead sponsor: University of Genova
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2012-10-30
Enrollment: 16
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the Orthodontic Department, Genoa University.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Canine movement
timeFrame: baseline and 3 months after starting treatment
Secondary outcomes:
measure: Side effect of traction
timeFrame: baseline and end of treatment
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: Orthodontics Department, Dental School, Genoa University. Italy
Study officials:
affiliation: Genoa University, Italy
name: Armando Silvestrini Biavati, MD, DDS
role: STUDY_DIRECTOR
affiliation: Genoa University, Italy
name: Marco Migliorati, DDS, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Migliorati M, Cevidanes L, Sinfonico G, Drago S, Dalessandri D, Isola G, Biavati AS. Three dimensional movement analysis of maxillary impacted canine using TADs: a pilot study. Head Face Med. 2021 Jan 15;17(1):1. doi: 10.1186/s13005-020-00252-0.