Dental Implant
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURERobot system
Prosthetically guided Implant placement utilising robotic surgery based on a digital plan
PROCEDUREFreehand surgery
Freehand implant placement by experienced surgeon.
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 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient with a single missing tooth to be replaced with a dental implant * With sufficient bone volume and keratinized tissue at edentulous site * Willing to comply with research appointments/schedule.
Exclusion criteria
* Pregnancy or intention to become pregnant at any point during the study duration * With any systemic diseases/conditions that are contraindications to dental implant treatment * Inability or unwillingness of individual to give written informed consent * Inability of follow-up according to the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant positional accuracy | Immediately after surgery | 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. |
| Peri-implant soft tissue health | 12 month follow-up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain perception | immediately after surgery, and 1 to 7 days after surgery | 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) . |
| Esthetics of the restoration | 12-months follow-up after delivery of crown | Assessed using the PES-WES scale as reported by Belser et al.with the scale ranging from 0 to 14 (worst to best) |
| Local integrity of the alveolar bone | Immediately after surgery | The thickness of the buccal and lingual bone plates 1, 3, and 5 mm apical to the implant platform on post-surgery CBCT |
| Submarginal microbiome | 12-months follow-up after delivery of crown | 16S assessment of microbiome diversity (Shannon index) with greater diversity representing a more stable microbiome |
| Cytokine concentrations in PISF | 12-months follow-up after delivery of crown | 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 |
| Discomfort perception | During surgery | 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) |
Countries
China
Outcome results
None listed