Dental ImplantNCT05919862
Accuracy of Dental Implant Placement Using a Collaborative Surgery Robot
A study testing Robot system and Freehand surgery in people with Dental Implant, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site 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?
- Robot system and Freehand surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2023to 30 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 to be replaced with a dental implant
- 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 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Oral and Maxillofacial Implantology
Shanghai, Shanghai Municipality, 200011
About this study
Official title: 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.
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. 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.
- Conditions
- Dental Implant
- Being tested
- Robot system, Freehand surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot systemProcedure or surgery
Prosthetically guided Implant placement utilising robotic surgery based on a digital plan
Freehand surgeryProcedure or surgery
Freehand implant placement by experienced surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Robot system | Experimental | Prosthetically guided Implant placement utilising robotic surgery based on a digital plan. Receives: Procedure: Robot system |
| Freehand surgery | Sham comparator | Freehand implant placement by experienced surgeon. Receives: Procedure: Freehand surgery |
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 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.
Measured: 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
Measured: 12 month follow-up
Secondary outcomes (6)
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
Measured: 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)
Measured: 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) .
Measured: 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)
Measured: 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
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 posted26 Jun 2023
- Study start16 Jun 2023
- Primary completion30 Jun 2023
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (actual)
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
- Tonetti Maurizio, PhD, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919862
- Sponsor's protocol ID
- SH9H-2023-05
- Status last verified
- Sep 2023
- First submitted
- 15 Jun 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
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
- Three-dimensional Positional Accuracy of Dental Implant Placement Using a Haptic and Machine Vision Controlled Collaborative Surgery Robot: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05919862
- Acronym / sponsor ID
- SH9H-2023-05
- Conditions
- Dental Implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 26 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot system | Experimental | Procedure: Robot systemProsthetically guided Implant placement utilising robotic surgery based on a digital plan. |
| Freehand surgery | Sham comparator | Procedure: Freehand surgeryFreehand implant placement by experienced surgeon. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Robot systemProsthetically guided Implant placement utilising robotic surgery based on a digital plan | Procedure or surgery | Robot system |
| Freehand surgeryFreehand implant placement by experienced surgeon. | Procedure or surgery | Freehand surgery |
Primary outcome
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
6 secondary outcomes
Local integrity of the alveolar bone
Time frame: Immediately after surgery
Discomfort perception
Time frame: During surgery
Pain perception
Time frame: immediately after surgery, and 1 to 7 days 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.
- 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.
Tonetti Maurizio, PhD principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot system and Freehand surgery in people with Dental Implant, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site 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 3 inclusion and 4 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 1 site 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
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.