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

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059573
• Other study ID #: 2022[07]
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2023
• Est. completion date: December 7, 2023

Study information

• Verified date: September 2023
• Source: Hospital of Stomatology, Wuhan University
• Contact: Zhenqi Chen, MD
• Phone: +86 13995544537
• Email: 1635156040[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 7, 2023
• Est. primary completion date: November 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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...

Related Conditions & MeSH terms

• Dental Implant

Intervention

Procedure:
• dental implant robot
Implant placement will be navigated by a dental implant robot based on a digital plan.
• Freehand surgery
Implant will be placed under freehand surgery.

Locations

Country	Name	City	State
China	School & Hospital of Stomatology, Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Qi Yan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgery complication	Complication related to implant placement surgery.	Immediately and seven days after surgery