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

Not Applicable

Recruiting

• Conditions: Dental Implant
• Interventions: Procedure: Freehand surgery; Procedure: dental implant robot

• Registration Number: NCT06059573
• Lead Sponsor: Qi Yan

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Study Start: 2023-10-07
• Primary Completion: 2023-11-07
• Study Completion: 2023-12-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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...

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Freehand surgery	Freehand surgery	Implant placement by freehand based on a digital plan
Robot-guided	dental implant robot	Implant placement by robot-guided based on a digital plan

Primary Outcome Measures

Name	Time	Method
Implant positional accuracy	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 Outcome Measures

Name	Time	Method
Surgery complication	Immediately and seven days after surgery	Complication related to implant placement surgery.

Trial Locations

Locations (1)

School & Hospital of Stomatology, Wuhan University; 🇨🇳 Wuhan, Hubei, China