Comparing Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area: A Randomized Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dental Implant
- Sponsor
- Tongji Hospital
- Enrollment
- 36
- Primary Endpoint
- implant positional accuracy
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Ke Song
Principal Investigator, Clinical Professor
Tongji Hospital
Eligibility Criteria
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
implant positional accuracy
Time Frame: 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 Outcomes
- Pain perception(immediately after surgery, and 1 to 7 days after surgery.)
- Surgery complication(Immediately and 7 days after surgery)