Evaluation of Maxillary Buccal Miniscrew Insertion Using Digital Guides (NCT07698730) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Maxillary Buccal Miniscrew Insertion Using Digital Guides
Vietnam33 participantsStarted 2025-11-01
Plain-language 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
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of Orthodontic Miniscrew Placement
Timeframe: Immediately after miniscrew placement
Trial details
NCT IDNCT07698730
SponsorCan Tho University of Medicine and Pharmacy