Dental Implant
Conditions
Keywords
Dental implant, Robotic system, Static navigation system
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.
Interventions
PROCEDURErobotic system
Implant placement will be navigated by robotic system based on a digital plan
PROCEDUREStatic navigation system
Implant placement will be navigated by static navigation system based on a digital plan
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| implant positional accuracy | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain perception | immediately after surgery, and 1 to 7 days after surgery. | 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) |
| Surgery complication | Immediately and 7 days after surgery | Complication related to implant placement surgery. |
Contacts
Primary ContactZhilin Luo, MD
Outcome results
None listed