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

Not Applicable

Not yet recruiting

• Conditions: Dental Implant
• Interventions: Procedure: robotic system; Procedure: Static navigation system

• Registration Number: NCT06173921
• Lead Sponsor: Tongji Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2023-12
• Study Start: 2023-12
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-14
• Last Update Submitted: 2023-12-14
• Study First Posted: 2023-12-18
• Last Update Posted: 2023-12-18
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic system	robotic system	implant placement by robotic surgery
Static system	Static navigation system	implant placement by static navigation surgery

Primary Outcome Measures

Name	Time	Method
implant positional accuracy	immediately after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Pain perception	immediately after surgery, and 1 to 7 days after surgery.	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)
Surgery complication	Immediately and 7 days after surgery	Complication related to implant placement surgery.