MalocclusionNCT02416297
Three- Dimensional Evaluation of Accelerated Tooth Movement
A study testing Micro-osteoperforation in people with Malocclusion, run by LIANA FATTORI ABATI at 1 site in Brazil.
Trial summary
The purpose of this research study is to assess the clinical effectiveness of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth movement in patients undergoing orthodontic treatment for orthognathic surgery. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Micro-osteoperforation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Jul 2018
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult subjects aged 18-35 years old, in good general health, with adult complete dentition, regardless of presence of third molars.
- Indication for orthognathic surgery
- Tooth extraction indication for orthodontic treatment
- Do not smoke
- Periodontal and teeth healthy
- Do not use bisphosphonates or corticosteroids
Who cannot join
- Surgically assisted rapid palatal expansion indication
- cleft lip and palate
- craniofacial syndrome
- mental disorder
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to assess the clinical effectiveness of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth movement in patients undergoing orthodontic treatment for orthognathic surgery. "Accelerated tooth movement" means that Microperforation technique may help complete orthodontic treatment sooner than would be expected in conventional orthodontic treatment
Read the detailed description
SAMPLE: For this prospective study, 22 subjects were selected, with skeletal discrepancies randomly divided into two groups: 1 - accelerated tooth movement technique (ATMT) and 2 - Control .
METHODS: MATERIAL - Orthodontic records done in two times, initial and preoperative; Plaster models of dental extracted jaw every 28 days converted in digital models; Cone Beam Computed tomography done in two times, initial and in the end of extraction space closure.
METHODS: Pre-molar extraction was performed before the Orthodontic Treatment to eliminate the RAP from the tooth extraction. After, at minimum 8 months for leveling, the extraction space closure was activated with light orthodontic traction (200 g each side) in anterior teeth, to maintain therapeutic osteopenia until contact point between the canine the second pre-molar is reached. Slide mechanic was chosen to performed anterior retraction on TADs in IZC.
Cortical perforations - ATMT Group: Flapless cortical micro-osteoperforations has been performed in the dental extraction area. Surgical protocol is flapless to preserve periodontal health. After local anesthesia, 3 micro osteoperforations are done with manual instrument, between the contour of free gum and tooth apex, and the canine and second pre-molar roots. The perforations near each tooth adjacent to the extraction area has 6-8 mm depth.
Results: On digital models - shortest distance between two adjacent teeth to the extraction space will be measured until the space closure.
Cone-Beam Computed Tomography: after image acquisition , data will be previously converted to DICOM , to converted to GIPL in ITK-SNAP 3.2 software. In Slicer software voxels will be converted to size 0.5 mm for further construction of virtual three-dimensional models, through segmentation of anatomical structures again in ITK-SNAP 3.2 software. This segmentation will be made by the full selection of all maxilla and mandible anatomically and individually, with the limit all skeletal outline available, including teeth. After 3D models generation, specific control targeting to fill all narrow spaces, so that they are not excluded from the virtual model and the external cortical displacements are the only ones to be computed in the comparative evaluation between later time. Then regional overlay 3D models will be done using Slicer software. For overlapping structures: In mandible will use along the edge of the mandibular symphysis; maxilla, posterior nasal spine. Overlap is automatic because software compares voxels grayscale to reference region to overlap spatially. Displacement evaluation will be done with Slicer software through colorful maps generated by calculating the distances between points of two representatives surfaces. These maps differentiate the movements between surfaces. For quantification metric, specific online tool is used to measure the displacement in millimeters. We will evaluate quantitative displacement for space closure, closing speed, the possible changes throughout the maxillomandibular complex and compared between groups. After collecting data, the results will be statistically analyzed.
- Conditions
- Malocclusion
- Being tested
- Micro-osteoperforation
- Keywords
- malocclusion, accelerated tooth movement, Tomography, Extraction
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-osteoperforationProcedure or surgery
Flapless cortical perforations will be made 8 months minimum after dental extraction. Surgical protocol will be flapless to preserve periodontal health. After local anesthesia, 3 micro osteoperforations will be done with manual instrument, between apex to the contour of free gum between the canine and second pre-molar. Perforations near each tooth will have 6-8 mm depth
| Study group | Role | What they receive |
|---|---|---|
| Micro-osteoperforation | Experimental | Minimally invasive micro-osteoperforation procedure used to achieve accelerated orthodontic tooth movement. Topical and local anesthetic will be delivered in the area to be treated in accordance with standard practice. Receives: Procedure: Micro-osteoperforation |
| Control | No intervention | Anterior retraction after premolars extraction will be done conventionally (slide mechanics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of velocity rate of anterior retraction in conventional mechanics and accelerated tooth movement technique
The micro osteoperforations accelerates tooth moviment - Null hipothesis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- LIANA FATTORI ABATI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LIANA FATTORI ABATI, University of Sao Paulo
- Investigators
- Jose R Neto, PhD, Study chair, University of Sao PauloLucia H Cevidanes, PhD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416297
- Sponsor's protocol ID
- Fattori-001
- Status last verified
- Jun 2019
- First submitted
- 27 Mar 2015
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three- Dimensional Evaluation of Accelerated Tooth Movement
- ClinicalTrials.gov ID
- NCT02416297
- Acronym / sponsor ID
- Fattori-001
- Conditions
- Malocclusion
- Keywords
- malocclusion, accelerated tooth movement, Tomography, Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- LIANA FATTORI ABATIUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 15 Apr 2015 (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.
The purpose of this research study is to assess the clinical effectiveness of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth movement in patients undergoing orthodontic treatment for orthognathic surgery. "Accelerated tooth movement" means that Microperforation technique may help complete orthodontic treatment sooner than would be expected in conventional orthodontic treatment
Detailed description
SAMPLE: For this prospective study, 22 subjects were selected, with skeletal discrepancies randomly divided into two groups: 1 - accelerated tooth movement technique (ATMT) and 2 - Control .
METHODS: MATERIAL - Orthodontic records done in two times, initial and preoperative; Plaster models of dental extracted jaw every 28 days converted in digital models; Cone Beam Computed tomography done in two times, initial and in the end of extraction space closure.
METHODS: Pre-molar extraction was performed before the Orthodontic Treatment to eliminate the RAP from the tooth extraction. After, at minimum 8 months for leveling, the extraction space closure was activated with light orthodontic traction (200 g each side) in anterior teeth, to maintain therapeutic osteopenia until contact point between the canine the second pre-molar is reached. Slide mechanic was chosen to performed anterior retraction on TADs in IZC.
Cortical perforations - ATMT Group: Flapless cortical micro-osteoperforations has been performed in the dental extraction area. Surgical protocol is flapless to preserve periodontal health. After local anesthesia, 3 micro osteoperforations are done with manual instrument, between the contour of free gum and tooth apex, and the canine and second pre-molar roots. The perforations near each tooth adjacent to the extraction area has 6-8 mm depth.
Results: On digital models - shortest distance between two adjacent teeth to the extraction space will be measured until the space closure.
Cone-Beam Computed Tomography: after image acquisition , data will be previously converted to DICOM , to converted to GIPL in ITK-SNAP 3.2 software. In Slicer software voxels will be converted to size 0.5 mm for further construction of virtual three-dimensional models, through segmentation of anatomical structures again in ITK-SNAP 3.2 software. This segmentation will be made by the full selection of all maxilla and mandible anatomically and individually, with the limit all skeletal outline available, including teeth. After 3D models generation, specific control targeting to fill all narrow spaces, so that they are not excluded from the virtual model and the external cortical displacements are the only ones to be computed in the comparative evaluation between later time. Then regional overlay 3D models will be done using Slicer software. For overlapping structures: In mandible will use along the edge of the mandibular symphysis; maxilla, posterior nasal spine. Overlap is automatic because software compares voxels grayscale to reference region to overlap spatially. Displacement evaluation will be done with Slicer software through colorful maps generated by calculating the distances between points of two representatives surfaces. These maps differentiate the movements between surfaces. For quantification metric, specific online tool is used to measure the displacement in millimeters. We will evaluate quantitative displacement for space closure, closing speed, the possible changes throughout the maxillomandibular complex and compared between groups. After collecting data, the results will be statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro-osteoperforation | Experimental | Procedure: Micro-osteoperforationMinimally invasive micro-osteoperforation procedure used to achieve accelerated orthodontic tooth movement. Topical and local anesthetic will be delivered in the area to be treated in accordance with standard practice. |
| Control | No intervention | –Anterior retraction after premolars extraction will be done conventionally (slide mechanics) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult subjects aged 18-35 years old, in good general health, with adult complete dentition, regardless of presence of third molars.
- Indication for orthognathic surgery
- Tooth extraction indication for orthodontic treatment
- Do not smoke
- Periodontal and teeth healthy
Key exclusion criteria (4 listed)
- Surgically assisted rapid palatal expansion indication
- cleft lip and palate
- craniofacial syndrome
- mental disorder
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 |
|---|---|---|
| Micro-osteoperforationFlapless cortical perforations will be made 8 months minimum after dental extraction. Surgical protocol will be flapless to preserve periodontal health. After local anesthesia, 3 micro osteoperforations will be done with manual instrument, between apex to the contour of free gum between the canine and second pre-molar. Perforations near each tooth will have 6-8 mm depth | Procedure or surgery | Micro-osteoperforation |
Primary outcome
Evaluation of velocity rate of anterior retraction in conventional mechanics and accelerated tooth movement technique
Time frame: 6 months
The micro osteoperforations accelerates tooth moviment - Null hipothesis
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 27 Jun 2019.
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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.
Jose R Neto, PhD study chair
University of Sao Paulo
Lucia H Cevidanes, PhD study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-osteoperforation in people with Malocclusion, run by LIANA FATTORI ABATI at 1 site in Brazil.
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 6 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 27 Jun 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 Brazil. 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?
Evaluation of velocity rate of anterior retraction in conventional mechanics and accelerated tooth movement technique (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2019.