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Evaluation of Maxillary Buccal Miniscrew Insertion Using Digital Guides

NCT07698730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-07-13

No results posted yet for this study

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

Conditions

  • Orthodontic Appliance Complication

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.

Sponsors & Collaborators

  • Can Tho University of Medicine and Pharmacy

    lead OTHER

Principal Investigators

  • Lam Nguyen Le, Assoc. Prof. · Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07698730 on ClinicalTrials.gov