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

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06173921
• Other study ID #: TJ-IRB20231192
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Tongji Hospital
• Contact: Zhilin Luo, MD
• Phone: 18667158923
• Email: ydysaa[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant
• Mouth, Edentulous

Intervention

Procedure:
• robotic system
Implant placement will be navigated by robotic system based on a digital plan
• Static navigation system
Implant placement will be navigated by static navigation system based on a digital plan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Surgery complication	Complication related to implant placement surgery.	Immediately and 7 days after surgery