Complicated Impacted ToothNCT01717417
Three Dimensional Movement Analysis of Maxillary Impacted Canine: a Randomized Clincial Trial
An observational study of Complicated Impacted Tooth, run by University of Genova at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Complicated Impacted Tooth
- What is being tested?
- miniscrew and TPA
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2011to 14 Apr 2019
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients referred to the Orthodontic Department, Genoa University.
Who may be able to join
- presence of one or two impacted maxillary canine requiring surgical exposure and orthodontic treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Orthodontics Department, Dental School, Genoa University. Italy
Genoa, 16100
About this study
Official title: Three Dimensional Movement Analysis of Maxillary Impacted Canine Using TADs: a Randomized Clinical 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.
Read more
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
- Being tested
- miniscrew, TPA
- Keywords
- impacted canine, miniscrew, cone beam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miniscrewDevice
TPADevice
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Patient treated with Trans Palatal Arch as anchorage for canine traction Receives: Device: TPA | |
| Group 2 | Patient treated with miniscrew as anchorage for canine traction Receives: Device: miniscrew |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 3 months after starting treatment
Secondary outcomes (1)
Side effect of traction
Evaluation of Root cervical resorption of other teeth due to canine movement Bone density after three month of traction
Measured: baseline and end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startSep 2011
- Primary completion1 Apr 2019
- Study completion14 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complicated Impacted ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- University of Genova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Marco Migliorati, University of Genova
- Investigators
- Armando Silvestrini Biavati, MD, DDS, Study director, Genoa University, ItalyMarco Migliorati, DDS, MSc, Principal investigator, Genoa University, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717417
- Sponsor's protocol ID
- MVM1
- Other IDs
- GU-1
- Status last verified
- Apr 2019
- First submitted
- 26 Oct 2012
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33451343
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Movement Analysis of Maxillary Impacted Canine Using TADs: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01717417
- Acronym / sponsor ID
- MVM1
- Conditions
- Complicated Impacted Tooth
- Keywords
- impacted canine, miniscrew, cone beam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of GenovaUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- Sep 2011
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 14 Apr 2019 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Device: TPAPatient treated with Trans Palatal Arch as anchorage for canine traction |
| Group 2 | – | Device: miniscrewPatient treated with miniscrew as anchorage for canine traction |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients referred to the Orthodontic Department, Genoa University.
Key inclusion criteria (1 listed)
- presence of one or two impacted maxillary canine requiring surgical exposure and orthodontic treatment
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miniscrew | Device | Group 2 |
| TPA | Device | group 1 |
Primary outcome
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
1 secondary outcome
Side effect of traction
Time frame: baseline and end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 33451343Migliorati 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armando Silvestrini Biavati, MD, DDS study director
Genoa University, Italy
Marco Migliorati, DDS, MSc principal investigator
Genoa University, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complicated Impacted Tooth, run by University of Genova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canine movement (time frame: baseline and 3 months after starting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01717417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.