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The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery

The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery: a Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06059573
Enrollment
28
Registered
2023-09-28
Start date
2023-10-07
Completion date
2023-12-07
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant

Keywords

robot-guided surgery, freehand, dental implant robot, accuracy

Brief summary

We plan to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery, to evaluate the accuracy of implant in both groups.

Detailed description

Oral implants have become a widely used treatment modality for patients with missing or edentulous teeth. Previous studies have shown that implant accuracy is associated with implant success and long-term outcomes. Therefore, we plant to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery. By comparing the preoperative planned implant position with the actual postoperative implant position using CBCT, we will evaluate the accuracy of implant in both groups.

Interventions

PROCEDUREdental implant robot

Implant placement will be navigated by a dental implant robot based on a digital plan.

Implant will be placed under freehand surgery.

Sponsors

Qi Yan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Single missing teeth with adjacent and opposing healthy natural teeth; 2. Healthy patients; 3. Sufficient alveolar bone available for implant placement.

Exclusion criteria

1. Pregnancy or intention to become pregnant at any point during the study duration 2. With any systemic diseases/conditions that are contraindications to dental implant...

Design outcomes

Primary

MeasureTime frameDescription
Implant positional accuracyimmediately after surgeryImplant accuracy will be measured as distance discrepancy at implant platform and implant apex, and angular discrepancy of implant axis between the digital plan and the actual position of the implant assessed digitally at the end of the procedure. Pre- and post-operative CBCT will be used for measurement.

Secondary

MeasureTime frameDescription
Surgery complicationImmediately and seven days after surgeryComplication related to implant placement surgery.

Countries

China

Contacts

Primary ContactZhenqi Chen, MD
1635156040@qq.com+86 13995544537

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026