Overview

This trial is active, not recruiting.

Condition malocclusion
Treatment micro-osteoperforation
Sponsor LIANA FATTORI ABATI
Start date April 2015
End date January 2016
Trial size 50 participants
Trial identifier NCT02416297, Fattori-001

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
micro-osteoperforation
Flapless cortical perforations will be made after dental extraction. Surgical protocol will be flapless to preserve periodontal health. After local anesthesia, minimum cortical perforations will be done with manual instrument, between 4-6 mm apical to the contour of free gum between the canine and second pre-molar. Two perforations near each tooth adjacent to the extraction area.
(No Intervention)
Anterior retraction after premolars extraction will be done conventionally

Primary Outcomes

Measure
Evaluation of velocity rate of anterior retraction in conventional mechanics and accelerated tooth movement technique
time frame: 6 months
Bone demineralization evaluation in extraction area using computerized tomography
time frame: 6 months

Eligibility Criteria

Male or female participants from 16 years up to 60 years old.

Inclusion Criteria: - Adolescent and adult subjects ages 16-55 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

Additional Information

Official title Three- Dimensional Evaluation of Accelerated Tooth Movement
Description SAMPLE: For this retrospective study, 50 individuals will be 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; Cone Beam Computed tomography done in two times, initial and in the end of extraction space closure. METHODS: Orthodontic Treatment: to activate extraction space closure, light orthodontic traction will be made in anterior teeth, to maintain therapeutic osteopenia until contact point between the canine the second pre -molar. Cortical perforations - ATMT Group: Flapless cortical perforations will be made after dental extraction. Surgical protocol will be flapless to preserve periodontal health. After local anesthesia, minimum cortical perforations will be done with manual instrument, between 4-6 mm apical to the contour of free gum between the canine and second pre-molar. Two perforations near each tooth adjacent to the extraction area. Results: On plaster models - shortest distance between two adjacent teeth to the extraction space will be measure with caliper. 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 Imagine 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 Imagine 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 Mirit 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. Ossification area volume will be compared using Hounsfield scale. After collecting data, the results will be statistically analyzed.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Sao Paulo.