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

NCT01717417 | Completed

• 2 other identifiers: MVM1GU-1
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Complicated Impacted Tooth

Keywords

impacted canine; miniscrew; cone beam

Outcome Measures

Primary Outcomes (1)

• Canine 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

  baseline and 3 months after starting treatment

Secondary Outcomes (1)

• Side effect of traction

  baseline and end of treatment

Study Arms (2)

group 1

Patient treated with Trans Palatal Arch as anchorage for canine traction

Device: TPA

Group 2

Patient treated with miniscrew as anchorage for canine traction

Device: miniscrew

Interventions

miniscrew DEVICE

Group 2

TPA DEVICE

group 1

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Orthodontic Department, Genoa University.

You may qualify if:

• presence of one or two impacted maxillary canine requiring surgical exposure and orthodontic treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Genova: lead
• University of Michigan: collaborator

Study Sites (1)

Orthodontics Department, Dental School, Genoa University. Italy

Genoa, 16100, Italy

Location

Related Publications (1)

• 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.

  PMID: 33451343 DERIVED

Study Officials

• Armando Silvestrini Biavati, MD, DDS

  Genoa University, Italy

  STUDY DIRECTOR

• Marco Migliorati, DDS, MSc

  Genoa University, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: October 30, 2012
• Study Start: September 1, 2011
• Primary Completion: April 1, 2019
• Study Completion: April 14, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

IT (1)