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CompletedNCT07155018MOPsUpdated Sep 4, 2025

Micro-Osteoperforations to Accelerate Maxillary Canine Retraction in Class I Malocclusion

An interventional study of Micro-osteoperforations (MOPs) and Conventional Canine Retraction in Malocclusion, Angle Class I, sponsored by Can Tho University of Medicine and Pharmacy. Completed at 1 site in Vietnam. Open to participants aged 16 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Can Tho University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
16 Years to 25 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Malocclusion, Angle Class I
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Who can participate

Ages eligible
16 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • History of craniofacial trauma or congenital anomalies
  • Systemic or bone-related diseases
  • Current smoking
  • Use of medications affecting bone metabolism
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Experimental: Micro-osteoperforations

    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.

    Procedure: Micro-osteoperforations (MOPs)

  • Active comparator
    Control: Conventional Retraction

    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.

    Procedure: Conventional Canine Retraction

Interventions

  • ProcedureMicro-osteoperforations (MOPs)

    Maxillary canine retraction with miniscrew anchorage and NiTi closed-coil springs, without micro-osteoperforations.

  • ProcedureConventional Canine Retraction

    Maxillary canine retraction with miniscrew anchorage and NiTi closed-coil springs, without micro-osteoperforations

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What researchers measure

Primary outcomes

  1. Rate of Maxillary Canine Retraction

    Distance of maxillary canine retraction measured on 3D digital dental models using intraoral scanning.

    Time frame: 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).

    Time frame: Day 1, Day 3, Day 7 after intervention

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Study locations

1 site
  • Can Tho University Hospital
    Can Tho, Vietnam
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References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared because the study has a small sample size and the data may compromise patient confidentiality.

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07155018
Lead sponsor
Can Tho University of Medicine and Pharmacy
Responsible party
Sponsor
First posted
Sep 4, 2025
Start date
Jan 1, 2025
Primary completion
Apr 30, 2025
Completion
Jun 30, 2025
Last update
Sep 4, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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