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

NCT ID: NCT07155018

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-06-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Micro-osteoperforations (MOPs)

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Conventional Canine Retraction

Intervention Type: PROCEDURE

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

Interventions

Micro-osteoperforations (MOPs)

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

Intervention Type: PROCEDURE

Conventional Canine Retraction

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Can Tho University of Medicine and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lam Nguyen Le, Ph.D.DDS

Role: STUDY_CHAIR

Department of Pediatrics Dentistry and Orthodontics, Faculty of Odonto- Stomatology, Can Tho University of Medicine and Pharmacy, Can Tho City, Vietnam

Locations

Can Tho University Hospital

Can Tho, , Vietnam

Countries

Vietnam

Other Identifiers

IRB-164-

Identifier Type: REGISTRY

Identifier Source: secondary_id

DuongThaoTrangCtump

Identifier Type: -

Identifier Source: org_study_id