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COMPLETED
NCT07698730
NA

Evaluation of Maxillary Buccal Miniscrew Insertion Using Digital Guides

Sponsor: Can Tho University of Medicine and Pharmacy

View on ClinicalTrials.gov

Summary

This randomized split-mouth clinical trial aims to compare the accuracy and clinical outcomes of CAD/CAM 3D-printed surgical guides with the conventional free-hand technique for orthodontic miniscrew placement in the posterior maxilla. Each participant will receive miniscrew placement using both techniques on opposite sides of the maxilla following random allocation. The primary outcome is placement accuracy assessed by three-dimensional positional and angular deviations between planned and actual miniscrew positions. Secondary outcomes include miniscrew stability, success rate after three months, postoperative pain, procedural time, patient satisfaction, and complications. The study also evaluates maxillary posterior cortical bone thickness using cone-beam computed tomography (CBCT) and investigates its relationship with miniscrew placement accuracy and stability

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2025-11-01

Completion Date

2026-06-01

Last Updated

2026-07-13

Healthy Volunteers

Yes

Interventions

DEVICE

CAD/CAM 3D-Printed Surgical Guide

A customized tooth-supported CAD/CAM-designed and 3D-printed surgical guide fabricated from CBCT and intraoral scan data to assist accurate orthodontic miniscrew insertion in the posterior maxilla according to the preoperative digital treatment plan.

PROCEDURE

Free-Hand Orthodontic Miniscrew Placement

Orthodontic miniscrews are inserted manually using the conventional free-hand technique without the assistance of a surgical guide, based on the clinician's clinical judgment and anatomical landmarks.

Locations (1)

Can Tho University of Medicine and Pharmacy

Can Tho, Vietnam