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Completed NCT07698730

Evaluation of Maxillary Buccal Miniscrew Insertion Using Digital Guides

Conditions: Orthodontic Appliance Complication

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 33
Sponsor: Can Tho University of Medicine and Pharmacy

Location: Can Tho University of Medicine and Pharmacy Can Tho

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

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 years or older. * Patients requiring bilateral orthodontic miniscrew placement in the posterior maxilla as part of orthodontic treatment. * Availability of high-quality cone-beam computed tomography (CBCT) images suitable for evaluation and digital planning. * Good general health and ability to undergo orthodontic treatment. * Healthy periodontal tissues at the planned miniscrew insertion sites. * Ability and willingness to provide written informed consent. Exclusion Criteria: * Systemic diseases or medications affecting bone healing or bone metabolism. * Bleeding disorders or contraindications to minor oral surgery. * Active periodontal disease or local infection at the planned insertion site. * Poor-quality or incomplete CBCT images. * Contraindications to CBCT imaging. * Pregnancy or lactation. * Previous orthodontic miniscrew placement in the planned insertion area. * Refusal or inability to provide informed consent.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07698730). StuddyBuddy aggregates publicly available trial information.