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Clinical Trials/NCT06059573
NCT06059573
Recruiting
Not Applicable

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

Qi Yan1 site in 1 country28 target enrollmentOctober 7, 2023
ConditionsDental Implant

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant
Sponsor
Qi Yan
Enrollment
28
Locations
1
Primary Endpoint
Implant positional accuracy
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 7, 2023
End Date
December 7, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Qi Yan
Responsible Party
Sponsor Investigator
Principal Investigator

Qi Yan

associate professor

Hospital of Stomatology, Wuhan University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Implant positional accuracy

Time Frame: immediately after surgery

Implant 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 Outcomes

  • Surgery complication(Immediately and seven days after surgery)

Study Sites (1)

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