- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05919862
Accuracy of Dental Implant Placement Using a Collaborative Surgery Robot
September 5, 2023 updated by: Maurizio Tonetti, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Three-dimensional Positional Accuracy of Dental Implant Placement Using a Haptic and Machine Vision Controlled Collaborative Surgery Robot: a Pilot Randomized Controlled Trial
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun-Yu Shi, PhD
- Phone Number: 13636340883
- Email: sjy0511@hotmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200011
- Department of Oral and Maxillofacial Implantology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Robot system
Prosthetically guided Implant placement utilising robotic surgery based on a digital plan.
|
Prosthetically guided Implant placement utilising robotic surgery based on a digital plan
|
Sham Comparator: Freehand surgery
Freehand implant placement by experienced surgeon.
|
Freehand implant placement by experienced surgeon.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Immediately after surgery
|
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
|
12 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Submarginal microbiome
Time Frame: 12-months follow-up after delivery of crown
|
16S assessment of microbiome diversity (Shannon index) with greater diversity representing a more stable microbiome
|
12-months follow-up after delivery of crown
|
Local integrity of the alveolar bone
Time Frame: 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
|
Immediately after surgery
|
Discomfort perception
Time Frame: 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)
|
During surgery
|
Pain perception
Time Frame: 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) .
|
immediately after surgery, and 1 to 7 days after surgery
|
Esthetics of the restoration
Time Frame: 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)
|
12-months follow-up after delivery of crown
|
Cytokine concentrations in PISF
Time Frame: 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
|
12-months follow-up after delivery of crown
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tonetti Maurizio, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 16, 2023
Primary Completion (Actual)
June 30, 2023
Study Completion (Estimated)
November 30, 2024
Study Registration Dates
First Submitted
June 15, 2023
First Submitted That Met QC Criteria
June 24, 2023
First Posted (Actual)
June 26, 2023
Study Record Updates
Last Update Posted (Actual)
September 7, 2023
Last Update Submitted That Met QC Criteria
September 5, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- SH9H-2023-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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