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

Tongji Hospital36 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Implant

Interventions

robotic systemPROCEDURE

Implant placement will be navigated by robotic system based on a digital plan

Static navigation systemPROCEDURE

Implant placement will be navigated by static navigation system based on a digital plan

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: immediately after surgery

Secondary Outcomes

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)

Time frame: immediately after surgery, and 1 to 7 days after surgery.

Surgery complication

Complication related to implant placement surgery.

Time frame: Immediately and 7 days after surgery

Central Contacts

Zhilin Luo, MD

CONTACT

18667158923 ydysaa@163.com

Data from ClinicalTrials.gov

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