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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implant
• Intervention / Treatment: Procedure: dental implant robot; Procedure: Freehand surgery

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 Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhenqi Chen, MD; Phone Number: +86 13995544537; Email: 1635156040@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430070
      • Recruiting
      • School & Hospital of Stomatology, Wuhan University
      • Contact: Zhenqi Chen, MD; Phone Number: +86 13995544537; Email: 1635156040@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-guided; Implant placement by robot-guided based on a digital plan	Procedure: dental implant robot; Implant placement will be navigated by a dental implant robot based on a digital plan.
Active Comparator: Freehand surgery; Implant placement by freehand based on a digital plan	Procedure: Freehand surgery; Implant will be placed under freehand surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant positional accuracy	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.	immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery complication	Complication related to implant placement surgery.	Immediately and seven days after surgery

Collaborators and Investigators

• Sponsor: Qi Yan
• Investigators: Principal Investigator: Qi Yan, PhD, School & Hospital of Stomatology, Wuhan University; Study Chair: Yufeng Zhang, PhD, School & Hospital of Stomatology, Wuhan University

Study record dates

Study Major Dates

• Study Start (Estimated): October 7, 2023
• Primary Completion (Estimated): November 7, 2023
• Study Completion (Estimated): December 7, 2023

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: accuracy; robot-guided surgery; freehand; dental implant robot
• Other Study ID Numbers: 2022[07]

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No