Orthodontic Tooth MovementMOPNCT05281588
Evaluation of Micro-osteoperforations to Accelerate Orthodontic Tooth Movement
A study testing Micro-osteoperforations in people with Orthodontic Tooth Movement, run by Pontifícia Universidade Católica de Minas Gerais at 1 site in Brazil.
Trial summary
This clinical trial evaluated the efficacy of micro osteoperforations in accelerating the retraction of maxillary incisors. Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Tooth Movement
- What is being tested?
- Micro-osteoperforations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2016to Mar 2020
- 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 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- both male and female subjects
- 16 or more years old
- orthodontic need of upper incisors extractions
- presence of all upper permanent teeth with exception of the third molars.
Who cannot join
- diseases and medications that were likely to affect bone biology
- pregnancy
- poor oral hygiene
- previous orthodontic treatment
- evidence of bone loss
- active periodontal disease
Show all 9Show fewer
- smoking
- syndromes or cleft patients
- severe crowding or Class II malocclusion (Pg-Nper > 18 mm, ANB > 7º, SN-GoGn > 38º e overjet > 10 mm).
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: Effects of Micro-osteoperforations on the Upper Incisors' Retraction: a Randomized Clinical Trial
This clinical trial evaluated the efficacy of micro osteoperforations in accelerating the retraction of maxillary incisors.
Read the detailed description
This single-centered randomized clinical trial evaluated the effects of micro-osteoperforations in the retraction of maxillary incisors in patients who required the extraction of the first premolars to correct malocclusion. The canine retraction was performed in a previous step. The possible effects of micro-osteoperforantions in the following parameters were 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
- Micro-osteoperforations
- Keywords
- Micro-osteoperforations, Orthodontic incisors retraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-osteoperforationsProcedure or surgery
Also called MOP
All micro-osteoperforations were performed only one time in the experimental group on the same day of the installation of the upper incisors' retraction mechanics. Perforations were 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 was controlled and standardized by a cursor developed and patented by the research group. Two micro-osteoperforations were aligned vertically distally from each upper incisor. Due to the proximity of the roots in the cervical third, only the most apical perforation was performed between the two central incisors. The first perforation was 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 |
|---|---|---|
| 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.
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 (3)
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 posted16 Mar 2022
- Study startFeb 2016
- Primary completionOct 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontifícia Universidade Católica de Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Sponsor
- Investigators
- Rodrigo V Soares, PhD, Study director, Pontifícia Universidade Católica de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281588
- Sponsor's protocol ID
- Micro-osteoperforations
- Acronym
- MOP
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research can be shared with others researchers.
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 41445469
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Micro-osteoperforations on the Upper Incisors' Retraction: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05281588
- Acronym / sponsor ID
- MOP / Micro-osteoperforations
- Conditions
- Orthodontic Tooth Movement
- Keywords
- Micro-osteoperforations, Orthodontic incisors retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Pontifícia Universidade Católica de Minas GeraisUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- Feb 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 16 Mar 2022 (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 clinical trial evaluated the efficacy of micro osteoperforations in accelerating the retraction of maxillary incisors.
Detailed description
This single-centered randomized clinical trial evaluated the effects of micro-osteoperforations in the retraction of maxillary incisors in patients who required the extraction of the first premolars to correct malocclusion. The canine retraction was performed in a previous step. The possible effects of micro-osteoperforantions in the following parameters were 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
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- both male and female subjects
- 16 or more years old
- orthodontic need of upper incisors extractions
- presence of all upper permanent teeth with exception of the third molars.
Key exclusion criteria (9 listed)
- diseases and medications that were likely to affect bone biology
- pregnancy
- poor oral hygiene
- previous orthodontic treatment
- evidence of bone loss
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 |
|---|---|---|
| Micro-osteoperforationsAlso: MOPAll micro-osteoperforations were performed only one time in the experimental group on the same day of the installation of the upper incisors' retraction mechanics. Perforations were 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 was controlled and standardized by a cursor developed and patented by the research group. Two micro-osteoperforations were aligned vertically distally from each upper incisor. Due to the proximity of the roots in the cervical third, only the most apical perforation was performed between the two central incisors. The first perforation was 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
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.
3 secondary outcomes
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 18 Mar 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.
- Individual participant dataSharing planned: Yes. The research can be shared with others researchers.
Related trials for Orthodontic Tooth Movement
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Not yet recruiting
Impact of Various Acceleration Techniques on En-masse Retraction of Maxillary Anterior Teeth
Accelerate Tooth Movement
Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Enrolling by invitation
Evaluation of Corticotomy-Assisted Canine Retraction Rate
Malocclusion, Corticotomy
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 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 9 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 18 Mar 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?
Anteroposterior displacement of the upper incisors (time frame: Up to 4 months). The study lists 2 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 NCT05281588, which also lists 1 linked publication.
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 18 Mar 2022.