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For free hand dental implant placement, a key difficulty is to accurately control the position. Improving precision of dental implant placement is considered important for safety and efficacy of tooth replacement with dental implants. The goal of this randomized controlled trial is to compare the positional implant accuracy, and patient reported outcomes comparing two methods of implant placement: the use of a robotic assisted surgery and freehand surgery. Patients requiring single tooth replacement with a dental implant will be digitally planned using a CBCT and an intraoral digital scan. Subjects will be randomized to one of the two 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 CBCT immediately after surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.
For free hand dental implant placement, a key difficulty is to accurately control the position. Improving precision of dental implant placement is considered important for safety and efficacy of tooth replacement with dental implants. In particular, more precise implant placement is expected to yield a better restoration both in terms of aesthetics and ability for self-performed oral hygiene and thus prevention of peri-implant diseases. The goal of this randomized controlled trial is to compare the positional implant accuracy, and patient reported outcomes comparing two methods of implant placement: the use of a robotic assisted surgery and freehand surgery. Patients requiring single tooth replacement with a dental implant will be digitally planned using a CBCT and an intraoral digital scan. Subjects will be randomized to one of the two 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 CBCT immediately after surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot system | Experimental | Prosthetically guided Implant placement utilising robotic surgery based on a digital plan. |
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| Freehand surgery | Sham Comparator | Freehand implant placement by experienced surgeon. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot system | Procedure | Prosthetically guided Implant placement utilising robotic surgery based on a digital plan |
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| Measure | Description | Time Frame |
|---|---|---|
| Implant positional accuracy | Implant accuracy will be measured as distance discrepancy at implant platform and implant apex, and angular discrepancy of implant axis between the digital plan and the actual position of the implant assessed digitally at the end of the procedure. Pre- and post-operative CBCT will be used for measurement. | Immediately after surgery |
| Peri-implant soft tissue health | Bleeding on probing and probing depth will be recorded, by probing gently around implant-supported restoration at six points: mesial-buccal, mid-buccal, distal-buccal, mesial-lingual, mid-lingual, and distal-lingual, using UNC-15 periodontal probe. This is defined according to the peri-implant health case definition by Berglundh et al 2017 and the ID-COSM international consensus conference | 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Local integrity of the alveolar bone | The thickness of the buccal and lingual bone plates 1, 3, and 5 mm apical to the implant platform on post-surgery CBCT | Immediately after surgery |
| Discomfort perception |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tonetti Maurizio, PhD | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillofacial Implantology | Shanghai | Shanghai Municipality | 200011 | China |
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| Freehand surgery | Procedure | Freehand implant placement by experienced surgeon. |
|
Patient discomfort 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)
| During surgery |
| Pain perception | Patient pain perception after surgery will be recorded using 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 |
| Esthetics of the restoration | Assessed using the PES-WES scale as reported by Belser et al.with the scale ranging from 0 to 14 (worst to best) | 12-months follow-up after delivery of crown |
| Cytokine concentrations in PISF | Cytokine concentration in peri-implant sulcus fluid assesed by MULTIPLEX ELISA as concentrations of IL-1, TNF, IL-6 with lower concentrations reflecting less local inflammation | 12-months follow-up after delivery of crown |
| Submarginal microbiome | 16S assessment of microbiome diversity (Shannon index) with greater diversity representing a more stable microbiome | 12-months follow-up after delivery of crown |