- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03089996
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
45
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: Piezocision
Piezocision-assisted canine retraction x Control (split mouth design)
|
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.
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)
|
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.
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)
|
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.
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
|
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:
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No Intervention: Control
Upper incisors retraction not associated with any clinical intervention to accelerate tooth movement
|
What is the study measuring?
Primary Outcome Measures
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
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.
Collaborators
Investigators
- 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.
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)
July 1, 2016
Primary Completion (Actual)
September 16, 2021
Study Completion (Actual)
September 16, 2021
Study Registration Dates
First Submitted
January 31, 2017
First Submitted That Met QC Criteria
March 19, 2017
First Posted (Actual)
March 24, 2017
Study Record Updates
Last Update Posted (Actual)
December 28, 2022
Last Update Submitted That Met QC Criteria
December 14, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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