Evaluation of Clinical Approaches to Accelerate Orthodontic Tooth Movement

December 14, 2022 updated by: Rodrigo Villamarim Soares, Pontifícia Universidade Católica de Minas Gerais

Piezocision, Corticotomy and Micro-ostoeperforations to Accelerate Orthodontic Tooth Movement

This study will compare the techniques of piezocision and alveolar corticotomies in accelerating orthodontic retraction movement of canines. In a second phase, this clinical trial will evaluate the effectiveness of micro-osteoperforations in accelerating the retraction of maxillary incisors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The first phase will consist of a split-mouth study in patients who require the extraction of the first premolars to correct malocclusion. The canine will be retracted using corticotomy and piezocision surgical techniques, as well as without any intervention, being this the control side. In addition, it will be evaluated the inflammatory biomarkers present in the gingival crevicular sulcus during the dental movement, as well as data related to pain and discomfort. The second phase will evaluate the effects of micro-osteoperforations in the retraction of maxillary incisors. The following parameters will be evaluated in the upper arch: anteroposterior incisors and first molars displacement, space closure, inclination and length of central incisors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil, 30535-610
        • Pontifícia Universidade Católica de Minas Gerais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with orthodontic need for bilateral upper first premolar extraction.
  • Adequate dento-oral health
  • ASA I and ASA II
  • Compliance with clinic visits every 2 weeks

Exclusion Criteria:

  • History of periodontal disease
  • Smokers
  • Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
  • Pregnancy
  • Presence of cleft or any syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Piezocision
Piezocision-assisted canine retraction x Control (split mouth design)
Procedure: Piezocision
The first maxillary premolars will be extracted with orthodontic purpose. After 3 months of extraction, the orthodontic alignment and dental leveling will be obtained and a 0.016x0.022 stainless steel wire will be placed, as well as orthodontic mini-implants (Morelli®, Sorocaba, SP, Brazil). The retraction of the canines will begin using closed nickel-titanium spring (120g). The piezocision surgery will be performed only in one side of the mouth. Three vertical piezo-incisions will be performed near the edentulous region and mesially to the canine root, in the vestibular alveolar cortical bone with the Ultrasonic instrument (BS1 insert Piezotome ™, Satelec Group Acteon Merignac, France) in depth of 3 mm. The intraoral digital scans will be performed with 7 and 14 days after the start of retraction, and then 14 in 14 days to a maximum period of 6 months. The patients will be advised to take analgesics (paracetamol or dipyrone) only if necessary.
Device: Control Side
The first maxillary premolars will be extracted with orthodontic purpose. Fixed orthodontic appliance will be bonded (0.022x0.025 slot with MBT prescription in incisors and Standart in the other teeth) with a power arm welded in the bracks upper canines brackets. After 3 months of extraction, the alignment and dental leveling will be obtained and a 0.016x0.022 stainless steel wire will be placed, as well as orthodontic mini-implants (Morelli®, Sorocaba, SP, Brazil) between the roots of the second premolars and molars. At that time an intra-oral digital scan will be performed. The retraction of the canines will begin using closed nickel-titanium spring (120g of force) from the power arm to the mini-implant. No surgery will be done at this side. The intraoral digital scans will be performed with 7 and 14 days after the start of retraction, and then 14 in 14 days to a maximum period of 6 months.
Experimental: Corticotomy
Corticotomy-assisted canine retraction x Control (split mouth design)
Device: Control Side
The first maxillary premolars will be extracted with orthodontic purpose. Fixed orthodontic appliance will be bonded (0.022x0.025 slot with MBT prescription in incisors and Standart in the other teeth) with a power arm welded in the bracks upper canines brackets. After 3 months of extraction, the alignment and dental leveling will be obtained and a 0.016x0.022 stainless steel wire will be placed, as well as orthodontic mini-implants (Morelli®, Sorocaba, SP, Brazil) between the roots of the second premolars and molars. At that time an intra-oral digital scan will be performed. The retraction of the canines will begin using closed nickel-titanium spring (120g of force) from the power arm to the mini-implant. No surgery will be done at this side. The intraoral digital scans will be performed with 7 and 14 days after the start of retraction, and then 14 in 14 days to a maximum period of 6 months.
Procedure: Corticotomy
The first maxillary premolars will be extracted with orthodontic purpose. After 3 months of extraction, the orthodontic alignment and dental leveling will be obtained and a 0.016x0.022 stainless steel wire will be placed, as well as orthodontic mini-implants (Morelli, Sorocaba, SP, Brazil).The retraction of the canines will begin using closed nickel-titanium spring (120g).The corticotomy surgery will be performed at the day of begining of canine retraction only in one side of the mouth.A mucoperiosteal flap will be raised from the extraction region to the mesial of the canine.Perforations will be performed using a number 2 spherical drill bit in low speed handpiece under irrigation, only in the cortical none depth.The intraoral digital scans will be performed with 7 and 14 days after the start of retraction, and then 14 in 14 days to a maximum period of 6 months.The patients will be advised to take analgesics (paracetamol or dipyrone) only if necessary.
Experimental: Piezocision x Corticotomy
Piezocision-assisted retraction x Corticotomy-assisted retraction (split mouth design)
Procedure: Piezocision
The first maxillary premolars will be extracted with orthodontic purpose. After 3 months of extraction, the orthodontic alignment and dental leveling will be obtained and a 0.016x0.022 stainless steel wire will be placed, as well as orthodontic mini-implants (Morelli®, Sorocaba, SP, Brazil). The retraction of the canines will begin using closed nickel-titanium spring (120g). The piezocision surgery will be performed only in one side of the mouth. Three vertical piezo-incisions will be performed near the edentulous region and mesially to the canine root, in the vestibular alveolar cortical bone with the Ultrasonic instrument (BS1 insert Piezotome ™, Satelec Group Acteon Merignac, France) in depth of 3 mm. The intraoral digital scans will be performed with 7 and 14 days after the start of retraction, and then 14 in 14 days to a maximum period of 6 months. The patients will be advised to take analgesics (paracetamol or dipyrone) only if necessary.
Procedure: Corticotomy
The first maxillary premolars will be extracted with orthodontic purpose. After 3 months of extraction, the orthodontic alignment and dental leveling will be obtained and a 0.016x0.022 stainless steel wire will be placed, as well as orthodontic mini-implants (Morelli, Sorocaba, SP, Brazil).The retraction of the canines will begin using closed nickel-titanium spring (120g).The corticotomy surgery will be performed at the day of begining of canine retraction only in one side of the mouth.A mucoperiosteal flap will be raised from the extraction region to the mesial of the canine.Perforations will be performed using a number 2 spherical drill bit in low speed handpiece under irrigation, only in the cortical none depth.The intraoral digital scans will be performed with 7 and 14 days after the start of retraction, and then 14 in 14 days to a maximum period of 6 months.The patients will be advised to take analgesics (paracetamol or dipyrone) only if necessary.
Experimental: Micro-osteoperforations
Micro-osteoperforations-assisted upper incisors retraction
Procedure: Micro-osteoperforations
All micro-osteoperforations will be performed only once time in the experimental group on the same day of the installation of the upper incisors' retraction mechanics. Perforations will be performed with an individualized surgical guide and a 1.6 mm diameter stainless steel surgical drill perpendicular to the alveolar bone, 3 mm deep on the buccal surface, and 5 mm, on the palate. The depth of the perforations will be controlled and standardized by a cursor developed and patented by the research group. Two micro-osteoperforations will be aligned vertically distally from each upper incisor. Due to the proximity of the roots in the cervical third, only the most apical perforation will be performed between the two central incisors. The first perforation will be performed 6 mm away from the gingival margin, and the second, 5 mm from the first, in the vertical direction.
Other Names:
  • MOP
No Intervention: Control
Upper incisors retraction not associated with any clinical intervention to accelerate tooth movement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Orthodontic Canine Retraction Rate
Time Frame: Up to 6 months
The main objective is to evaluate and compare the canine retraction velocity in the different groups. Digital intra-oral scans will be performed (3Shape A / S®, Kopenhagen, Denmark) as registration method, every 14 days, up to 6 months.
Up to 6 months
Anteroposterior displacement of the upper incisors
Time Frame: Up to 4 months
The anteroposterior displacement of the upper incisors was assessed on superimposed digital models through the distance of points on the incisal edge and palatal cervical margin of these teeth to a coronal reference plan created on the initial CBCT scan.
Up to 4 months
Space closure
Time Frame: Up to 4 months
The space closure was assessed by the distance between the most menial point of the medial surface of the canine to the most distal point of the distal surface of the lateral incisor.
Up to 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of the effect of the surgical procedures
Time Frame: Up to 6 months
The retraction of the canine will be accompanied by up to 6 months after surgery to verify the duration of its effect, if it occurs.
Up to 6 months
Evaluation of biomarkers
Time Frame: Up to 6 months
To evaluate the expression of the inflammatory biomarkers present in the gingival crevicular sulcus of the canines to be retracted. At T0, immediately before retraction, and 15 in 15 days.
Up to 6 months
Patient Pain and discomfort
Time Frame: Up to 6 months
VAS questionnaire will be used after the surgical procedures, as well after TADs placement, separator placement and premolar extraction. Always 7 days after each procedure.
Up to 6 months
First molars anchorage loss
Time Frame: Up to 4 months
The first molars anchorage loss was assessed on superimposed digital models through the distance of a point on the mesiobuccal cuspid to a coronal reference plan created on the initial CBCT scan.
Up to 4 months
Changes of the inclination of the central incisors
Time Frame: Up to 4 months
The initial and final CBCT were superimposed by the "voxel-based method" in the Dolphin Imaging software (Chatsworth, CA, USA), using the cranial base as reference. The inclination of the central incisors was then assessed by means of the angle formed by the long axis of each central incisor in the initial and final CBCT.
Up to 4 months
Changes of the length of the central incisors
Time Frame: Up to 4 months
The initial and final length of the central incisors were measured by creating a 2D line, passing through the lowest point of the incisal edge and the highest point of the root apex. To perform these measurements, a sagittal cut was used in which the longest length of these teeth was seen.
Up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pontifícia Universidade Católica de Minas Gerais

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa do estado de Minas Gerais

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rodrigo V Soares, PhD, Pontifícia Universidade Católica de Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Accelerate Tooth Movement

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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