Dental ImplantNCT05892406
Accuracy of Dental Implant Position Robotic Assistance, Dynamic Navigation, or Static Guide?
A study testing Static guide, Dynamic navigation and Robotic system in people with Dental Implant, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- Static guide, Dynamic navigation and Robotic system
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2023to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with a single missing tooth, with sufficient bone volume and keratinized tissue at edentulous site, willing to comply with research appointments/schedule.
Who cannot join
- Pregnancy or intention to become pregnant at any point during the study duration; with any systematic diseases/conditions that are contradictions to dental implant treatment; inability or unwillingness of individual to give written informed consent; inability of follow-up according to the protocol.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Department of Oral and Maxillofacial Implantology
Shanghai, Shanghai Municipality, 200011
Jun-Yu Shi, MDS, 23271073
- Recruiting
Shanghai Perio-Implant Innovation Center
Shanghai, Shanghai Municipality, 201206
Jojo Qian, PhD, qianshujiao@gmail.com
About this study
Official title: 3 Dimensional Accuracy of Dental Implant Placement: Randomised Controlled Trial Comparing Robotic Assistance, Dynamic Navigation, and Static Guide
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. There are 3 available methods to improve implant position according to a digitally constructed prosthetically guided plan: the use of a 3D printed static guide, the use of a dynamic navigation system or the use of a robotic system. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction among three methods of digital guidance: the use of a 3D printed static guide, dynamic navigation, and robotic assisted 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 three 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 follow-up scan taken at the end of the surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.
Read the 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. There are 3 available methods to improve implant position according to a digitally constructed prosthetically guided plan: the use of a 3D printed static guide, the use of a dynamic navigation system or the use of a robotic system. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction among three methods of digital guidance: the use of a 3D printed static guide, dynamic navigation, and robotic assisted 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 three 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 follow-up scan taken at the end of the surgery. Platform deviation will be measured digitally. Subjects will be followed up for one year to assess both patient reported and professional outcomes and associate them with the precision of implant position.
- Conditions
- Dental Implant
- Being tested
- Static guide, Dynamic navigation, Robotic system
- Keywords
- robotic surgery, dynamic surgical navigation, 3D printed static guide, Accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static guideDevice
A static guide will be designed and fabricated based on CBCT and intra-oral scan. Implant will be placed under the assistance of statistic guide through the whole procedure.
Dynamic navigationDevice
Implant will be placed under the assistance of dynamic navigation.
Robotic systemDevice
Implant will be placed under robotic arm and human collaboration.
| Study group | Role | What they receive |
|---|---|---|
| Static guide | Active comparator | Prosthetically guided Implant placement utilising a 3D printed static guide based on a digital plan Receives: Device: Static guide |
| Dynamic navigation | Active comparator | Prosthetically guided Implant placement utilising a dynamic navigation system based on a digital plan Receives: Device: Dynamic navigation |
| Robotic system | Experimental | Prosthetically guided Implant placement utilising robotic surgery based on a digital plan Receives: Device: Robotic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant positional accuracy
Implant accuracy will be measured as discrepancy between the digital plan and t actual position of the implant.
Measured: Immediately after surgery
Peri-implant soft tissue health
Defined according to the peri-implant health case definition by Berglundh et al 2017 and the ID-COSM international consensus conference
Measured: 12 month follow-up
Secondary outcomes (8)
Surgery time
Time needed for surgery procedure will be recorded from anaesthesia to connection of cover screw/healing abutment.
Measured: intraoperative
Pain perception
Patient pain 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) .
Measured: Immediately after 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) .
Measured: 7 days after surgery
Patient preference
Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option.
Measured: Immediately after surgery
Surgeon preference
Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option.
Measured: Immediately after surgery
Esthetics of the restoration
Assessed using the PES-WES scale as reported by Belser et al. with 0 being the worst and 14 the best value in the scale
Measured: 12-months follow-up after delivery of crown
Cytokine concentrations in PISF
Cytokine concentration in peri-implant sulcus fluid assesed by MULTIPLEX ELISA of IL-1, TNFa, IL-6 with lower concentrations representing less inflammation.
Measured: 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
Measured: 12-months follow-up after delivery of crown
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jul 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Tonetti, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Maurizio Tonetti, PhD, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892406
- Sponsor's protocol ID
- SH9H-2023-T109
- Status last verified
- Sep 2023
- First submitted
- 29 May 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi JY, Wu XY, Lv XL, Liu M, Fu XJ, Liu BL, Lai HC, Tonetti MS. Comparison of Implant Precision with Robots, Navigation, or Static Guides. J Dent Res. 2025 Jan;104(1):37-44. doi: 10.1177/00220345241285566. Epub 2024 Nov 25.
PubMed 39586816
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3 Dimensional Accuracy of Dental Implant Placement: Randomised Controlled Trial Comparing Robotic Assistance, Dynamic Navigation, and Static Guide
- ClinicalTrials.gov ID
- NCT05892406
- Acronym / sponsor ID
- SH9H-2023-T109
- Conditions
- Dental Implant
- Keywords
- robotic surgery, dynamic surgical navigation, 3D printed static guide, Accuracy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. There are 3 available methods to improve implant position according to a digitally constructed prosthetically guided plan: the use of a 3D printed static guide, the use of a dynamic navigation system or the use of a robotic system. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction among three methods of digital guidance: the use of a 3D printed static guide, dynamic navigation, and robotic assisted 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 three 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 follow-up scan taken at the end of the 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. There are 3 available methods to improve implant position according to a digitally constructed prosthetically guided plan: the use of a 3D printed static guide, the use of a dynamic navigation system or the use of a robotic system. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction among three methods of digital guidance: the use of a 3D printed static guide, dynamic navigation, and robotic assisted 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 three 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 follow-up scan taken at the end of the surgery. Platform deviation will be measured digitally. Subjects will be followed up for one year to assess both patient reported and professional outcomes and associate them with the precision of implant position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Static guide | Active comparator | Device: Static guideProsthetically guided Implant placement utilising a 3D printed static guide based on a digital plan |
| Dynamic navigation | Active comparator | Device: Dynamic navigationProsthetically guided Implant placement utilising a dynamic navigation system based on a digital plan |
| Robotic system | Experimental | Device: Robotic systemProsthetically guided Implant placement utilising robotic surgery based on a digital plan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with a single missing tooth, with sufficient bone volume and keratinized tissue at edentulous site, willing to comply with research appointments/schedule.
Key exclusion criteria (1 listed)
- Pregnancy or intention to become pregnant at any point during the study duration; with any systematic diseases/conditions that are contradictions to dental implant treatment; inability or unwillingness of individual to give written informed consent; inability of follow-up according to the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static guideA static guide will be designed and fabricated based on CBCT and intra-oral scan. Implant will be placed under the assistance of statistic guide through the whole procedure. | Device | Static guide |
| Dynamic navigationImplant will be placed under the assistance of dynamic navigation. | Device | Dynamic navigation |
| Robotic systemImplant will be placed under robotic arm and human collaboration. | Device | Robotic system |
Primary outcome
Implant positional accuracy
Time frame: Immediately after surgery
Implant accuracy will be measured as discrepancy between the digital plan and t actual position of the implant.
Peri-implant soft tissue health
Time frame: 12 month follow-up
Defined according to the peri-implant health case definition by Berglundh et al 2017 and the ID-COSM international consensus conference
8 secondary outcomes
Surgery time
Time frame: intraoperative
Pain perception
Time frame: Immediately after surgery
Pain perception
Time frame: 7 days after surgery
Patient preference
Time frame: Immediately after surgery
Surgeon preference
Time frame: Immediately after surgery
Esthetics of the restoration
Time frame: 12-months follow-up after delivery of crown
Cytokine concentrations in PISF
Time frame: 12-months follow-up after delivery of crown
Submarginal microbiome
Time frame: 12-months follow-up after delivery of crown
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 39586816Shi JY, Wu XY, Lv XL, Liu M, Fu XJ, Liu BL, Lai HC, Tonetti MS. Comparison of Implant Precision with Robots, Navigation, or Static Guides. J Dent Res. 2025 Jan;104(1):37-44. doi: 10.1177/00220345241285566. Epub 2024 Nov 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Tonetti, PhD principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static guide, Dynamic navigation and Robotic system in people with Dental Implant, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun-Yu Shi, PhD (13636340883, sjy0511@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant positional accuracy (time frame: Immediately after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05892406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.