Three-dimensional Positional Accuracy of Dental Implant Placement Using a Haptic and Machine Vision Controlled Collaborative Surgery Robot: a Pilot Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Implant
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Implant positional accuracy
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Maurizio Tonetti
Professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Implant positional accuracy
Time Frame: 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
Time Frame: 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 Outcomes
- Local integrity of the alveolar bone(Immediately after surgery)
- Pain perception(immediately after surgery, and 1 to 7 days after surgery)
- Cytokine concentrations in PISF(12-months follow-up after delivery of crown)
- Submarginal microbiome(12-months follow-up after delivery of crown)
- Discomfort perception(During surgery)
- Esthetics of the restoration(12-months follow-up after delivery of crown)