Dental ImplantNCT06173921
The Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area
A study testing robotic system and Static navigation system in people with Dental Implant, run by Tongji Hospital.
Trial summary
The aim of this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- robotic system and Static navigation system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent form signed voluntarily.
- Aged at least 18 years.
- Partial edentulousness in the posterior maxillary or mandibular region (premolar, molar, maximum two in a row).
- Sufficient bone volume for implant placement without bone augmentation;
- The minimum number of residual teeth was seven teeth.
- Good communication with the physician, compliance, ability to follow the physician's advice to maintain oral hygiene.
Who cannot join
- Systemic disease that would interfere with dental implant surgery.
- Bisphosphonate treatment.
- Untreated, uncontrolled periodontal disease.
- Heavy smoker (more than 10 cigarettes per day).
- Poor oral hygiene.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparing Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area: A Randomized Clinical Trial
The aim of this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.
Read the detailed description
Dental implants have been widely used for replacing the lost natural teeth, with evidence of long-term success and improvement of patients' quality of life. Nevertheless, proper implant position is considered today an essential prerequisite for ensuring successful treatment outcomes, as well as long-term maintenance of the prosthesis and the peri-implant tissue health.Therefore, we plan to conduct this randomized clinical trialto compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.
- Conditions
- Dental Implant
- Being tested
- robotic system, Static navigation system
- Keywords
- Dental implant, Robotic system, Static navigation system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic systemProcedure or surgery
Implant placement will be navigated by robotic system based on a digital plan
Static navigation systemProcedure or surgery
Implant placement will be navigated by static navigation system based on a digital plan
| Study group | Role | What they receive |
|---|---|---|
| Robotic system | Experimental | implant placement by robotic surgery Receives: Procedure: robotic system |
| Static system | Active comparator | implant placement by static navigation surgery Receives: Procedure: Static navigation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant positional accuracy
The implant placement accuracy was measured by overlapping the planned position of the implant in the preoperative CBCT and its final position assessed through a postoperative CBCT.
Measured: immediately after surgery
Secondary outcomes (2)
Pain perception
patient pain perception after surgery will recorded by 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.
Surgery complication
Complication related to implant placement surgery.
Measured: Immediately and 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 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 Tongji HospitalThe 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke Song, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173921
- Sponsor's protocol ID
- TJ-IRB20231192
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- 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 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Accuracy of Static Navigation Systems and Robotic System in Partially Edentulous in Posterior Area: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06173921
- Acronym / sponsor ID
- TJ-IRB20231192
- Conditions
- Dental Implant
- Keywords
- Dental implant, Robotic system, Static navigation system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Dec 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.
The aim of this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.
Detailed description
Dental implants have been widely used for replacing the lost natural teeth, with evidence of long-term success and improvement of patients' quality of life. Nevertheless, proper implant position is considered today an essential prerequisite for ensuring successful treatment outcomes, as well as long-term maintenance of the prosthesis and the peri-implant tissue health.Therefore, we plan to conduct this randomized clinical trialto compare the implant positional accuracy of robotic system-assisted implant surgery with that of static system-assisted implant surgery. Patients will be recruited and randomly assigned to either the robotic surgery group or the static navigation surgery group to evaluate the accuracy of the implants in both groups and to compare patient-reported and physician-reported outcomes of the two approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic system | Experimental | Procedure: robotic systemimplant placement by robotic surgery |
| Static system | Active comparator | Procedure: Static navigation systemimplant placement by static navigation surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent form signed voluntarily.
- Aged at least 18 years.
- Partial edentulousness in the posterior maxillary or mandibular region (premolar, molar, maximum two in a row).
- Sufficient bone volume for implant placement without bone augmentation;
- The minimum number of residual teeth was seven teeth.
Key exclusion criteria (5 listed)
- Systemic disease that would interfere with dental implant surgery.
- Bisphosphonate treatment.
- Untreated, uncontrolled periodontal disease.
- Heavy smoker (more than 10 cigarettes per day).
- Poor oral hygiene.
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 |
|---|---|---|
| robotic systemImplant placement will be navigated by robotic system based on a digital plan | Procedure or surgery | Robotic system |
| Static navigation systemImplant placement will be navigated by static navigation system based on a digital plan | Procedure or surgery | Static system |
Primary outcome
implant positional accuracy
Time frame: immediately after surgery
The implant placement accuracy was measured by overlapping the planned position of the implant in the preoperative CBCT and its final position assessed through a postoperative CBCT.
2 secondary outcomes
Pain perception
Time frame: immediately after surgery, and 1 to 7 days after surgery.
Surgery complication
Time frame: Immediately and 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 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.
Questions about this trial
What is this clinical trial studying?
A study testing robotic system and Static navigation system in people with Dental Implant, run by Tongji Hospital.
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 6 inclusion and 5 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 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Zhilin Luo, MD (18667158923, ydysaa@163.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). 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 18 Dec 2023.