Three- Dimensional Evaluation of Accelerated Tooth Movement
Primary Purpose
Malocclusion
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Micro-osteoperforation
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion focused on measuring malocclusion, accelerated tooth movement, Tomography, Extraction
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Surgically assisted rapid palatal expansion indication
- cleft lip and palate
- craniofacial syndrome
- mental disorder
Sites / Locations
- FOUSP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Micro-osteoperforation
Control
Arm Description
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.
Anterior retraction after premolars extraction will be done conventionally (slide mechanics)
Outcomes
Primary Outcome Measures
Evaluation of velocity rate of anterior retraction in conventional mechanics and accelerated tooth movement technique
The micro osteoperforations accelerates tooth moviment - Null hipothesis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02416297
Brief Title
Three- Dimensional Evaluation of Accelerated Tooth Movement
Official Title
Three- Dimensional Evaluation of Accelerated Tooth Movement
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
LIANA FATTORI ABATI
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. "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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
malocclusion, accelerated tooth movement, Tomography, Extraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Micro-osteoperforation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Anterior retraction after premolars extraction will be done conventionally (slide mechanics)
Intervention Type
Procedure
Intervention Name(s)
Micro-osteoperforation
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluation of velocity rate of anterior retraction in conventional mechanics and accelerated tooth movement technique
Description
The micro osteoperforations accelerates tooth moviment - Null hipothesis
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Surgically assisted rapid palatal expansion indication
cleft lip and palate
craniofacial syndrome
mental disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose R Neto, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lucia H Cevidanes, PhD
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
FOUSP
City
Sao Paulo
ZIP/Postal Code
05508000
Country
Brazil
12. IPD Sharing Statement
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Three- Dimensional Evaluation of Accelerated Tooth Movement
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