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

NCT07155018 | Completed

• 2 other identifiers: DuongThaoTrangCtumpIRB-164-
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion, Angle Class I

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Pain Level (VAS Score)

  Day 1, Day 3, Day 7 after intervention

Study Arms (2)

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.

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.

Procedure: Conventional Canine Retraction

Interventions

Micro-osteoperforations (MOPs) PROCEDURE

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

Experimental: Micro-osteoperforations

Conventional Canine Retraction PROCEDURE

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

Control: Conventional Retraction

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Can Tho University Hospital

Can Tho, Vietnam

Location

MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: January 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)