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

Tongji Hospital

Status: Not yet enrolling

Conditions: Dental Implant

Treatments: Procedure: robotic system; Procedure: Static navigation system

Study type: Interventional

Funder types: Other

Identifiers

NCT06173921

TJ-IRB20231192

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Robotic system

Experimental group

Description:

implant placement by robotic surgery

Treatment:

Procedure: robotic system

Static system

Active Comparator group

Description:

implant placement by static navigation surgery

Treatment:

Procedure: Static navigation system