Orthodontic Appliance ComplicationNCT07698730
Evaluation of Maxillary Buccal Miniscrew Insertion Using Digital Guides
A study testing CAD/CAM 3D-Printed Surgical Guide and Free-Hand Orthodontic Miniscrew Placement in people with Orthodontic Appliance Complication, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- CAD/CAM 3D-Printed Surgical Guide and Free-Hand Orthodontic Miniscrew Placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Nov 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Orthodontic miniscrews have become an effective source of temporary skeletal anchorage because they provide absolute anchorage with minimal dependence on patient compliance. However, the success of orthodontic miniscrews largely depends on accurate insertion while avoiding adjacent anatomical structures, particularly dental roots and the maxillary sinus. Incorrect placement may lead to root damage, instability, or failure of the miniscrew Cone-beam computed tomography (CBCT) allows three-dimensional evaluation of alveolar bone morphology and cortical bone thickness before miniscrew insertion. Digital technologies combining CBCT, intraoral scanning, CAD/CAM planning, and three-dimensional printing have enabled fabrication of customized surgical guides designed to improve insertion accuracy This study is designed as a randomized split-mouth controlled clinical trial. Patients requiring bilateral orthodontic miniscrews in the posterior maxilla will receive one miniscrew inserted using a CAD/CAM 3D-printed surgical guide and the contralateral miniscrew inserted using the conventional free-hand technique. The side allocated to each intervention and the order of insertion will be randomized Placement accuracy will be evaluated by superimposing preoperative planning data with postoperative digital models using Geomagic Studio software. Three-dimensional deviations, including coronal and apical positional deviations and angular deviations, will be calculated. Miniscrew stability, success rate after three months, postoperative pain measured by the Visual Analog Scale (VAS), patient satisfaction, operative time, and treatment-related complications will also be evaluated. Additionally, CBCT will be used to measure cortical bone thickness at multiple posterior maxillary interradicular sites, and correlations between cortical bone thickness and miniscrew accuracy and stability will be analyzed
- Conditions
- Orthodontic Appliance Complication
- Being tested
- CAD/CAM 3D-Printed Surgical Guide, Free-Hand Orthodontic Miniscrew Placement
- Keywords
- Orthodontic Miniscrew, 3D Printing, CBCT, Surgical Guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM 3D-Printed Surgical GuideDevice
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.
Free-Hand Orthodontic Miniscrew PlacementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM-Guided Miniscrew Placement | Experimental | Miniscrew placement using a customized CAD/CAM 3D-printed surgical guide. Receives: Device: CAD/CAM 3D-Printed Surgical Guide |
| Free-Hand Miniscrew Placement | Active comparator | Conventional free-hand orthodontic miniscrew placement. Receives: Procedure: Free-Hand Orthodontic Miniscrew Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Orthodontic Miniscrew Placement
Placement accuracy will be assessed by comparing the planned and actual miniscrew positions using digital superimposition. Coronal and apical three-dimensional deviations together with angular deviations will be calculated using Geomagic Studio software.
Measured: Immediately after miniscrew placement
Secondary outcomes (3)
Miniscrew Success Rate
Clinical success defined as stable miniscrews remaining functional for orthodontic anchorage.
Measured: 3 months
Miniscrew Stability
Clinical assessment of miniscrew stability after insertion.
Measured: Immediately after insertion, 1 week, 1 month, and 3 months.
Three-Dimensional Miniscrew Displacement
Changes in miniscrew position between immediate postoperative and 3-month evaluations
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Nov 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lam Nguyen Le, Assoc. Prof., Principal investigator, Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698730
- Sponsor's protocol ID
- LeNguyenLam
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Maxillary Buccal Miniscrew Insertion Using Digital Guides
- ClinicalTrials.gov ID
- NCT07698730
- Acronym / sponsor ID
- LeNguyenLam
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Orthodontic Miniscrew, 3D Printing, CBCT, Surgical Guide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Orthodontic miniscrews have become an effective source of temporary skeletal anchorage because they provide absolute anchorage with minimal dependence on patient compliance. However, the success of orthodontic miniscrews largely depends on accurate insertion while avoiding adjacent anatomical structures, particularly dental roots and the maxillary sinus. Incorrect placement may lead to root damage, instability, or failure of the miniscrew Cone-beam computed tomography (CBCT) allows three-dimensional evaluation of alveolar bone morphology and cortical bone thickness before miniscrew insertion. Digital technologies combining CBCT, intraoral scanning, CAD/CAM planning, and three-dimensional printing have enabled fabrication of customized surgical guides designed to improve insertion accuracy This study is designed as a randomized split-mouth controlled clinical trial. Patients requiring bilateral orthodontic miniscrews in the posterior maxilla will receive one miniscrew inserted using a CAD/CAM 3D-printed surgical guide and the contralateral miniscrew inserted using the conventional free-hand technique. The side allocated to each intervention and the order of insertion will be randomized Placement accuracy will be evaluated by superimposing preoperative planning data with postoperative digital models using Geomagic Studio software. Three-dimensional deviations, including coronal and apical positional deviations and angular deviations, will be calculated. Miniscrew stability, success rate after three months, postoperative pain measured by the Visual Analog Scale (VAS), patient satisfaction, operative time, and treatment-related complications will also be evaluated. Additionally, CBCT will be used to measure cortical bone thickness at multiple posterior maxillary interradicular sites, and correlations between cortical bone thickness and miniscrew accuracy and stability will be analyzed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM-Guided Miniscrew Placement | Experimental | Device: CAD/CAM 3D-Printed Surgical GuideMiniscrew placement using a customized CAD/CAM 3D-printed surgical guide. |
| Free-Hand Miniscrew Placement | Active comparator | Procedure: Free-Hand Orthodontic Miniscrew PlacementConventional free-hand orthodontic miniscrew placement. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAD/CAM 3D-Printed Surgical GuideA 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. | Device | CAD/CAM-Guided Miniscrew Placement |
| Free-Hand Orthodontic Miniscrew PlacementOrthodontic 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. | Procedure or surgery | Free-Hand Miniscrew Placement |
Primary outcome
Accuracy of Orthodontic Miniscrew Placement
Time frame: Immediately after miniscrew placement
Placement accuracy will be assessed by comparing the planned and actual miniscrew positions using digital superimposition. Coronal and apical three-dimensional deviations together with angular deviations will be calculated using Geomagic Studio software.
3 secondary outcomes
Miniscrew Success Rate
Time frame: 3 months
Miniscrew Stability
Time frame: Immediately after insertion, 1 week, 1 month, and 3 months.
Three-Dimensional Miniscrew Displacement
Time frame: 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lam Nguyen Le, Assoc. Prof. principal investigator
Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM 3D-Printed Surgical Guide and Free-Hand Orthodontic Miniscrew Placement in people with Orthodontic Appliance Complication, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Orthodontic Miniscrew Placement (time frame: Immediately after miniscrew placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.