Orthodontic Tooth MovementNCT03089996
Evaluation of Clinical Approaches to Accelerate Orthodontic Tooth Movement
A study testing Piezocision, Corticotomy and Micro-osteoperforations in people with Orthodontic Tooth Movement, run by Pontifícia Universidade Católica de Minas Gerais at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Tooth Movement
- What is being tested?
- Piezocision, Corticotomy and Micro-osteoperforations
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2016to 16 Sep 2021
- 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 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pontifícia Universidade Católica de Minas Gerais
Belo Horizonte, Minas Gerais, 30535-610
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthodontic Tooth Movement
- Being tested
- Piezocision, Corticotomy, Control Side, Micro-osteoperforations
- Keywords
- piezocision, corticotomy, Gingival Crevicular Fluid, Micro-osteperforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiezocisionProcedure or surgery
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.
CorticotomyProcedure or surgery
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.
Control SideDevice
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.
Micro-osteoperforationsProcedure or surgery
Also called MOP
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.
| Study group | Role | What they receive |
|---|---|---|
| Piezocision | Experimental | Piezocision-assisted canine retraction x Control (split mouth design) Receives: Procedure: Piezocision; Device: Control Side |
| Corticotomy | Experimental | Corticotomy-assisted canine retraction x Control (split mouth design) Receives: Procedure: Corticotomy; Device: Control Side |
| Piezocision x Corticotomy | Experimental | Piezocision-assisted retraction x Corticotomy-assisted retraction (split mouth design) Receives: Procedure: Piezocision; Procedure: Corticotomy |
| Micro-osteoperforations | Experimental | Micro-osteoperforations-assisted upper incisors retraction Receives: Procedure: Micro-osteoperforations |
| Control | No intervention | Upper incisors retraction not associated with any clinical intervention to accelerate tooth movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthodontic Canine Retraction Rate
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.
Measured: Up to 6 months
Anteroposterior displacement of the upper incisors
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.
Measured: Up to 4 months
Space closure
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.
Measured: Up to 4 months
Secondary outcomes (6)
Duration of the effect of the surgical procedures
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.
Measured: Up to 6 months
Evaluation of biomarkers
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.
Measured: Up to 6 months
Patient Pain and discomfort
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.
Measured: Up to 6 months
First molars anchorage loss
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.
Measured: Up to 4 months
Changes of the inclination of the central incisors
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.
Measured: Up to 4 months
Changes of the length of the central incisors
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.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Jul 2016
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Tooth MovementStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontifícia Universidade Católica de Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Rodrigo Villamarim Soares, Pontifícia Universidade Católica de Minas Gerais
- Investigators
- Rodrigo V Soares, Phd, Study director, Pontifícia Universidade Católica de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089996
- Sponsor's protocol ID
- Accelerate Tooth Movement
- Status last verified
- Dec 2022
- First submitted
- 31 Jan 2017
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mordente CM, Dores LS, Oliveira DD, Palomo JM, Souki BQ, Soares RV. Third Palatal Rugae as Stable Landmarks for Intraoral Models' Superimposition in Extraction Cases: A Retrospective Cohort Study. Orthod Craniofac Res. 2026 Apr;29(2):326-335. doi: 10.1111/ocr.70078. Epub 2025 Dec 25.
PubMed 41445469Mordente CM, Oliveira DD, Palomo JM, Cardoso PA, Assis MAL, Zenobio EG, Souki BQ, Soares RV. The effect of micro-osteoperforations on the rate of maxillary incisors' retraction in orthodontic space closure: a randomized controlled clinical trial. Prog Orthod. 2024 Feb 12;25(1):6. doi: 10.1186/s40510-023-00505-z.
PubMed 38342823Fernandes LSDMCP, Figueiredo DSF, Oliveira DD, Houara RG, Rody WJ Jr, Gribel BF, Soares RV. The effects of corticotomy and piezocision in orthodontic canine retraction: a randomized controlled clinical trial. Prog Orthod. 2021 Oct 4;22(1):37. doi: 10.1186/s40510-021-00367-3.
PubMed 34604918
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piezocision, Corticotomy and Micro-ostoeperforations to Accelerate Orthodontic Tooth Movement
- ClinicalTrials.gov ID
- NCT03089996
- Acronym / sponsor ID
- Accelerate Tooth Movement
- Conditions
- Orthodontic Tooth Movement
- Keywords
- piezocision, corticotomy, Gingival Crevicular Fluid, Micro-osteperforations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Pontifícia Universidade Católica de Minas GeraisUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 24 Mar 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Piezocision | Experimental | Procedure: Piezocision, Device: Control SidePiezocision-assisted canine retraction x Control (split mouth design) |
| Corticotomy | Experimental | Procedure: Corticotomy, Device: Control SideCorticotomy-assisted canine retraction x Control (split mouth design) |
| Piezocision x Corticotomy | Experimental | Procedure: Piezocision, Procedure: CorticotomyPiezocision-assisted retraction x Corticotomy-assisted retraction (split mouth design) |
| Micro-osteoperforations | Experimental | Procedure: Micro-osteoperforationsMicro-osteoperforations-assisted upper incisors retraction |
| Control | No intervention | –Upper incisors retraction not associated with any clinical intervention to accelerate tooth movement |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| PiezocisionThe 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 or surgery | Piezocision, Piezocision x Corticotomy |
| CorticotomyThe 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. | Procedure or surgery | Corticotomy, Piezocision x Corticotomy |
| Control SideThe 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. | Device | Corticotomy, Piezocision |
| Micro-osteoperforationsAlso: MOPAll 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. | Procedure or surgery | Micro-osteoperforations |
Primary outcome
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.
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.
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.
6 secondary outcomes
Duration of the effect of the surgical procedures
Time frame: Up to 6 months
Evaluation of biomarkers
Time frame: Up to 6 months
Patient Pain and discomfort
Time frame: Up to 6 months
First molars anchorage loss
Time frame: Up to 4 months
Changes of the inclination of the central incisors
Time frame: Up to 4 months
Changes of the length of the central incisors
Time frame: Up to 4 months
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 28 Dec 2022.
- Derived from this study: PubMed 41445469Mordente CM, Dores LS, Oliveira DD, Palomo JM, Souki BQ, Soares RV. Third Palatal Rugae as Stable Landmarks for Intraoral Models' Superimposition in Extraction Cases: A Retrospective Cohort Study. Orthod Craniofac Res. 2026 Apr;29(2):326-335. doi: 10.1111/ocr.70078. Epub 2025 Dec 25.
- Derived from this study: PubMed 38342823Mordente CM, Oliveira DD, Palomo JM, Cardoso PA, Assis MAL, Zenobio EG, Souki BQ, Soares RV. The effect of micro-osteoperforations on the rate of maxillary incisors' retraction in orthodontic space closure: a randomized controlled clinical trial. Prog Orthod. 2024 Feb 12;25(1):6. doi: 10.1186/s40510-023-00505-z.
- Derived from this study: PubMed 34604918Fernandes LSDMCP, Figueiredo DSF, Oliveira DD, Houara RG, Rody WJ Jr, Gribel BF, Soares RV. The effects of corticotomy and piezocision in orthodontic canine retraction: a randomized controlled clinical trial. Prog Orthod. 2021 Oct 4;22(1):37. doi: 10.1186/s40510-021-00367-3.
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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.
Rodrigo V Soares, Phd study director
Pontifícia Universidade Católica de Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezocision, Corticotomy and Micro-osteoperforations in people with Orthodontic Tooth Movement, run by Pontifícia Universidade Católica de Minas Gerais 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 4 inclusion and 5 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 28 Dec 2022. 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?
Orthodontic Canine Retraction Rate (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03089996, which also lists 3 linked publications.
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 28 Dec 2022.