Complicated Impacted Tooth Clinical Trial
Official title:
Three Dimensional Movement Analysis of Maxillary Impacted Canine Using TADs: a Randomized Clinical Trial
| NCT number | NCT01717417 |
| Other study ID # | MVM1 |
| Secondary ID | GU-1 |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2011 |
| Est. completion date | April 14, 2019 |
| Verified date | April 2019 |
| Source | University of Genova |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | April 14, 2019 |
| Est. primary completion date | April 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years to 60 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Orthodontics Department, Dental School, Genoa University. Italy | Genoa |
| Lead Sponsor | Collaborator |
|---|---|
| University of Genova | University of Michigan |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Side effect of traction | Evaluation of Root cervical resorption of other teeth due to canine movement Bone density after three month of traction | baseline and end of treatment |