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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-164- | Registry Identifier | Ethics Committee of Can Tho University of Medicine and Pharmacy |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micro-osteoperforations (MOPs) | Procedure | Maxillary canine retraction with miniscrew anchorage and NiTi closed-coil springs, without micro-osteoperforations. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Maxillary Canine Retraction | Distance of maxillary canine retraction measured on 3D digital dental models using intraoral scanning. | Baseline, 4, 8, 12, and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 1, Day 3, Day 7 after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lam Nguyen Le, Ph.D.DDS | Department of Pediatrics Dentistry and Orthodontics, Faculty of Odonto- Stomatology, Can Tho University of Medicine and Pharmacy, Can Tho City, Vietnam | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Can Tho University Hospital | Can Tho | Vietnam |
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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| ID | Term |
|---|---|
| D008311 | Malocclusion, Angle Class I |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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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.
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Only the outcome assessor was blinded to the intervention allocation. Patients and treating clinicians were aware of the intervention side, but the examiner performing digital measurements and statistical analysis did not know which side received MOPs.
| Conventional Canine Retraction | Procedure | Maxillary canine retraction with miniscrew anchorage and NiTi closed-coil springs, without micro-osteoperforations |
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