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

NCT06173921 | Unknown

• 1 other identifier: TJ-IRB20231192
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Implant

Keywords

Dental implant; Robotic system; Static navigation system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain perception

  immediately after surgery, and 1 to 7 days after surgery.

• Surgery complication

  Immediately and 7 days after surgery

Study Arms (2)

Robotic system

EXPERIMENTAL

implant placement by robotic surgery

Procedure: robotic system

Static system

ACTIVE COMPARATOR

implant placement by static navigation surgery

Procedure: Static navigation system

Interventions

robotic system PROCEDURE

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

Robotic system

Static navigation system PROCEDURE

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

Static system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Central Study Contacts

Zhilin Luo, MD

CONTACT

18667158923; ydysaa@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 18, 2023
• Study Start: December 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share