The Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area

Comparing Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area: A Randomized Clinical Trial

The aim of this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Implant
• Intervention / Treatment: Procedure: robotic system; Procedure: Static navigation system

Detailed Description

Dental implants have been widely used for replacing the lost natural teeth, with evidence of long-term success and improvement of patients' quality of life. Nevertheless, proper implant position is considered today an essential prerequisite for ensuring successful treatment outcomes, as well as long-term maintenance of the prosthesis and the peri-implant tissue health.Therefore, we plan to conduct this randomized clinical trialto compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhilin Luo, MD; Phone Number: 18667158923; Email: ydysaa@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Informed consent form signed voluntarily.
• Aged at least 18 years.
• Partial edentulousness in the posterior maxillary or mandibular region (premolar, molar, maximum two in a row).
• Sufficient bone volume for implant placement without bone augmentation;
• The minimum number of residual teeth was seven teeth.
• Good communication with the physician, compliance, ability to follow the physician's advice to maintain oral hygiene.

Exclusion criteria:

• Systemic disease that would interfere with dental implant surgery.
• Bisphosphonate treatment.
• Untreated, uncontrolled periodontal disease.
• Heavy smoker (more than 10 cigarettes per day).
• Poor oral hygiene.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic system; implant placement by robotic surgery	Procedure: robotic system; Implant placement will be navigated by robotic system based on a digital plan
Active Comparator: Static system; implant placement by static navigation surgery	Procedure: Static navigation system; Implant placement will be navigated by static navigation system based on a digital plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant positional accuracy	The implant placement accuracy was measured by overlapping the planned position of the implant in the preoperative CBCT and its final position assessed through a postoperative CBCT.	immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception	patient pain perception after surgery will recorded by visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience)	immediately after surgery, and 1 to 7 days after surgery.
Surgery complication	Complication related to implant placement surgery.	Immediately and 7 days after surgery

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Dental implant; Robotic system; Static navigation system
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: TJ-IRB20231192

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
• product manufactured in and exported from the U.S.: No