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

NCT ID: NCT01717417

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2019-04-14

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

group 1

Patient treated with Trans Palatal Arch as anchorage for canine traction

TPA

Intervention Type: DEVICE

Group 2

Patient treated with miniscrew as anchorage for canine traction

miniscrew

Intervention Type: DEVICE

Interventions

miniscrew

Intervention Type: DEVICE

TPA

Intervention Type: DEVICE

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

University of Genova

OTHER

Sponsor Role: lead

Responsible Party

Marco Migliorati

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Armando Silvestrini Biavati, MD, DDS

Role: STUDY_DIRECTOR

Genoa University, Italy

Marco Migliorati, DDS, MSc

Role: PRINCIPAL_INVESTIGATOR

Genoa University, Italy

Locations

Orthodontics Department, Dental School, Genoa University. Italy

Genoa, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 33451343 (View on PubMed)

Other Identifiers

GU-1

Identifier Type: OTHER

Identifier Source: secondary_id

MVM1

Identifier Type: -

Identifier Source: org_study_id