Accuracy of Dental Implant Placement Using a Collaborative Surgery Robot

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Three-dimensional Positional Accuracy of Dental Implant Placement Using a Haptic and Machine Vision Controlled Collaborative Surgery Robot: a Pilot Randomized Controlled Trial

Conditions
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Dental Implant

Intervention / Treatment
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* Procedure: Robot system
* Procedure: Freehand surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot system<br>Prosthetically guided Implant placement utilising robotic surgery based on a digital plan. | Procedure: Robot system<br>* Prosthetically guided Implant placement utilising robotic surgery based on a digital plan<br>|
| Sham Comparator: Freehand surgery<br>Freehand implant placement by experienced surgeon. | Procedure: Freehand surgery<br>* Freehand implant placement by experienced surgeon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |