Tooth Diseases
Conditions
Keywords
immediate implant placement, dynamic navigation, robotic surgery
Brief summary
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning in immediate implant placement compared to free hand procedure. On the basis of dynamic navigation, robotic system uses the robotic arm to replace the manual process of implant bed preparation and implant placement, therefore improving the accuracy of implant placement theoretically. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction between dynamic navigation and robotic assisted immediate implant placement in maxillae. Subjects will be randomized to either group based on the allocation. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up CBCT scan taken at the end of the surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.
Detailed description
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning in immediate implant placement compared to free hand procedure. However, dynamic navigation faces the following deficiencies in immediate implant placement. Firstly, it has a steep learning curve. Secondly, the rigid palatal bone wall of the socket will force the direction of drill deviating buccally. On the basis of dynamic navigation, robotic system uses the robotic arm to replace the manual process of implant bed preparation and implant placement, therefore improving the accuracy of implant placement theoretically. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction between dynamic navigation and robotic assisted immediate implant placement in maxillae. Subjects will be randomized to either treatment modalities based on the plan. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a follow-up scan taken at the end of the surgery. Subjects will be followed up for one year to assess the professional outcomes.
Interventions
PROCEDUREdynamic navigation surgery
immediate implant placement assisted by dynamic navigation
PROCEDURErobotic surgery
immediate implant placement assisted by robotic surgery
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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
No
Inclusion criteria
* a. ≥18 years old and in good health; b. One or more maxillary incisors that cannot be retained due to non-periodontitis; c. The buccal bone plate is intact; d. No acute infection; e. The extraction socket have at least 3-5 mm apical bone.
Exclusion criteria
* a. General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids); b. Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy); c. Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm; d. Heavy smokers or previous heavy smoking history (quit smoking time \<5 years or\> 20 cigarettes per day); e. Refuse to participate in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant positional accuracy | immediately after surgery | Implant accuracy will be measured as discrepancy between the digital plan and the actual position of the implant. (Global deviation at platform and apex, Angular deviation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgery time | intraoperative | Time needed for surgery procedure will be recorded from anaesthesia to connection of cover screw/healing abutment. |
| Pain perception | Immediately after surgery | Patient pain perception during surgery will be recorded using visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience). |
| Surgeon preference | Immediately after surgery | Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option. |
| Soft tissue changes | immediately after crown delivery | Assessed by midfacial recession, mesial and distal papillary recession. |
Countries
China
Contacts
CONTACTYijie Zhang, Master
Outcome results
None listed