Malocclusion, Angle Class IMOPsNCT07155018
Micro-Osteoperforations to Accelerate Maxillary Canine Retraction in Class I Malocclusion
A study testing Micro-osteoperforations (MOPs) and Conventional Canine Retraction in people with Malocclusion, Angle Class I, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
This single-blinded, split-mouth randomized controlled trial investigates whether micro-osteoperforations (MOPs) can accelerate maxillary canine retraction in orthodontic patients requiring bilateral premolar extraction. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class I
- What is being tested?
- Micro-osteoperforations (MOPs) and Conventional Canine Retraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2025to 30 Jun 2025
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16-25 years
- Patients requiring bilateral extraction of maxillary first premolars as part of orthodontic treatment
- Angle Class I molar relationship
- No previous orthodontic treatment
Who cannot join
- History of craniofacial trauma or congenital anomalies
- Systemic or bone-related diseases
- Current smoking
- Use of medications affecting bone metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Micro-Osteoperforations (MOPs) in Accelerating Maxillary Canine Retraction in Angle Class I Malocclusion: A Randomized Controlled Trial.
This single-blinded, split-mouth randomized controlled trial investigates whether micro-osteoperforations (MOPs) can accelerate maxillary canine retraction in orthodontic patients requiring bilateral premolar extraction. The study also evaluates postoperative pain levels using the Visual Analog Scale at 1, 3, and 7 days.
Read the detailed description
MOPs are a flapless, minimally invasive surgical technique that stimulates bone remodeling and may reduce orthodontic treatment time. In this trial, one side of each patient receives MOPs while the contralateral side serves as control. Canine retraction is performed using miniscrews, power arms, and NiTi coil springs. Outcomes include the rate of canine movement over 16 weeks and pain assessment using VAS.
- Conditions
- Malocclusion, Angle Class I
- Being tested
- Micro-osteoperforations (MOPs), Conventional Canine Retraction
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-osteoperforations (MOPs)Procedure or surgery
Maxillary canine retraction with miniscrew anchorage and NiTi closed-coil springs, without micro-osteoperforations.
Conventional Canine RetractionProcedure or surgery
Maxillary canine retraction with miniscrew anchorage and NiTi closed-coil springs, without micro-osteoperforations
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Micro-osteoperforations | Experimental | On the experimental side, micro-osteoperforations (MOPs) were performed distal to the maxillary canine under local anesthesia using the Excellerator RT device. Three perforations, each 1.5 mm in diameter and 5 mm deep, were created in the attached gingiva. Canine retraction was then carried out using miniscrew anchorage and NiTi closed-coil springs. Receives: Procedure: Micro-osteoperforations (MOPs) |
| Control: Conventional Retraction | Active comparator | On the control side, maxillary canine retraction was performed using miniscrew anchorage and NiTi closed-coil springs without any micro-osteoperforations. The mechanics were identical to the experimental side to ensure comparability. Receives: Procedure: Conventional Canine Retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Maxillary Canine Retraction
Distance of maxillary canine retraction measured on 3D digital dental models using intraoral scanning.
Measured: Baseline, 4, 8, 12, and 16 weeks
Secondary outcomes (1)
Pain Level (VAS Score)
atient-reported pain intensity measured using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: Day 1, Day 3, Day 7 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Jan 2025
- Primary completion30 Apr 2025
- Study completion30 Jun 2025
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 Malocclusion, Angle Class IStudies 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
- Crossover
- Model description
- This is a single-blinded, split-mouth randomized controlled trial. Each participant received both interventions: on one side of the maxillary arch, micro-osteoperforations (MOPs) were performed distal to the canine, while the contralateral side served as the control with conventional retraction. Outcomes were measured within the same patient, reducing inter-individual variability.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lam Nguyen Le, Ph.D.DDS, Study chair, Department of Pediatrics Dentistry and Orthodontics, Faculty of Odonto- Stomatology, Can Tho University of Medicine and Pharmacy, Can Tho City, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155018
- Sponsor's protocol ID
- DuongThaoTrangCtump
- Other IDs
- IRB-164-
- Acronym
- MOPs
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study has a small sample size and the data may compromise patient confidentiality.
Publications
Duong TT, Le LN, Truong NBT. "Effectiveness of micro-osteoperforations in accelerating maxillary canine retraction in Angle Class I malocclusion: A randomized controlled trial". J Orthod Sci. 2026 Sep 16;15:28. doi: 10.4103/jos.jos_165_25. eCollection 2026.
PubMed 42852432
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Micro-Osteoperforations (MOPs) in Accelerating Maxillary Canine Retraction in Angle Class I Malocclusion: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07155018
- Acronym / sponsor ID
- MOPs / DuongThaoTrangCtump
- Conditions
- Malocclusion, Angle Class I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 4 Sep 2025 (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 single-blinded, split-mouth randomized controlled trial investigates whether micro-osteoperforations (MOPs) can accelerate maxillary canine retraction in orthodontic patients requiring bilateral premolar extraction. The study also evaluates postoperative pain levels using the Visual Analog Scale at 1, 3, and 7 days.
Detailed description
MOPs are a flapless, minimally invasive surgical technique that stimulates bone remodeling and may reduce orthodontic treatment time. In this trial, one side of each patient receives MOPs while the contralateral side serves as control. Canine retraction is performed using miniscrews, power arms, and NiTi coil springs. Outcomes include the rate of canine movement over 16 weeks and pain assessment using VAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-blinded, split-mouth randomized controlled trial. Each participant received both interventions: on one side of the maxillary arch, micro-osteoperforations (MOPs) were performed distal to the canine, while the contralateral side served as the control with conventional retraction. Outcomes were measured within the same patient, reducing inter-individual variability.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Micro-osteoperforations | Experimental | Procedure: Micro-osteoperforations (MOPs)On the experimental side, micro-osteoperforations (MOPs) were performed distal to the maxillary canine under local anesthesia using the Excellerator RT device. Three perforations, each 1.5 mm in diameter and 5 mm deep, were created in the attached gingiva. Canine retraction was then carried out using miniscrew anchorage and NiTi closed-coil springs. |
| Control: Conventional Retraction | Active comparator | Procedure: Conventional Canine RetractionOn the control side, maxillary canine retraction was performed using miniscrew anchorage and NiTi closed-coil springs without any micro-osteoperforations. The mechanics were identical to the experimental side to ensure comparability. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 16-25 years
- Patients requiring bilateral extraction of maxillary first premolars as part of orthodontic treatment
- Angle Class I molar relationship
- No previous orthodontic treatment
Key exclusion criteria (4 listed)
- History of craniofacial trauma or congenital anomalies
- Systemic or bone-related diseases
- Current smoking
- Use of medications affecting bone metabolism
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-osteoperforations (MOPs)Maxillary canine retraction with miniscrew anchorage and NiTi closed-coil springs, without micro-osteoperforations. | Procedure or surgery | Experimental: Micro-osteoperforations |
| Conventional Canine RetractionMaxillary canine retraction with miniscrew anchorage and NiTi closed-coil springs, without micro-osteoperforations | Procedure or surgery | Control: Conventional Retraction |
Primary outcome
Rate of Maxillary Canine Retraction
Time frame: Baseline, 4, 8, 12, and 16 weeks
Distance of maxillary canine retraction measured on 3D digital dental models using intraoral scanning.
1 secondary outcome
Pain Level (VAS Score)
Time frame: Day 1, Day 3, Day 7 after intervention
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 4 Sep 2025.
- Derived from this study: PubMed 42852432Duong TT, Le LN, Truong NBT. "Effectiveness of micro-osteoperforations in accelerating maxillary canine retraction in Angle Class I malocclusion: A randomized controlled trial". J Orthod Sci. 2026 Sep 16;15:28. doi: 10.4103/jos.jos_165_25. eCollection 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study has a small sample size and the data may compromise patient confidentiality.
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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.
Lam Nguyen Le, Ph.D.DDS study chair
Department of Pediatrics Dentistry and Orthodontics, Faculty of Odonto- Stomatology, Can Tho University of Medicine and Pharmacy, Can Tho City, Vietnam
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 (MOPs) and Conventional Canine Retraction in people with Malocclusion, Angle Class I, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
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 4 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 4 Sep 2025. 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 Vietnam. 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?
Rate of Maxillary Canine Retraction (time frame: Baseline, 4, 8, 12, and 16 weeks). 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 NCT07155018, 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 4 Sep 2025.