Dental ImplantNCT06059573
The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery
A study testing dental implant robot and Freehand surgery in people with Dental Implant, run by Qi Yan at 1 site in China.
Trial summary
We plan to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand 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?
- dental implant robot and Freehand surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2023to 7 Dec 2023
- 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
- Single missing teeth with adjacent and opposing healthy natural teeth;
- Healthy patients;
- Sufficient alveolar bone available for implant placement.
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...
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School & Hospital of Stomatology, Wuhan University
Wuhan, Hubei, 430070
Zhenqi Chen, MD, +86 13995544537, 1635156040@qq.com
About this study
Official title: The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery: a Randomized Clinical Trial
We plan to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery, to evaluate the accuracy of implant in both groups.
Read the detailed description
Oral implants have become a widely used treatment modality for patients with missing or edentulous teeth. Previous studies have shown that implant accuracy is associated with implant success and long-term outcomes. Therefore, we plant to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery. By comparing the preoperative planned implant position with the actual postoperative implant position using CBCT, we will evaluate the accuracy of implant in both groups.
- Conditions
- Dental Implant
- Being tested
- dental implant robot, Freehand surgery
- Keywords
- robot-guided surgery, freehand, dental implant robot, accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant robotProcedure or surgery
Implant placement will be navigated by a dental implant robot based on a digital plan.
Freehand surgeryProcedure or surgery
Implant will be placed under freehand surgery.
| Study group | Role | What they receive |
|---|---|---|
| Robot-guided | Experimental | Implant placement by robot-guided based on a digital plan Receives: Procedure: dental implant robot |
| Freehand surgery | Active comparator | Implant placement by freehand based on a digital plan 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
Secondary outcomes (1)
Surgery complication
Complication related to implant placement surgery.
Measured: Immediately and seven 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 posted28 Sep 2023
- Study start7 Oct 2023 (estimated)
- Primary completion7 Nov 2023 (estimated)
- Study completion7 Dec 2023 (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.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qi Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qi Yan, Hospital of Stomatology, Wuhan University
- Investigators
- Qi Yan, PhD, Principal investigator, School & Hospital of Stomatology, Wuhan UniversityYufeng Zhang, PhD, Study chair, School & Hospital of Stomatology, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059573
- Sponsor's protocol ID
- 2022[07]
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo Z, Zhou W, Wang M, Xu L, Du X, Cao Y, Song K. Accuracy, Efficiency, and Patient- and Surgeon-Reported Outcomes of Static Versus Robotic Computer-Assisted Implant Surgery: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 May 28. doi: 10.1111/clr.70138. Online ahead of print.
PubMed 42210518
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Dental Implant Placement Using Robotic System-assisted Surgery and Freehand Surgery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06059573
- Acronym / sponsor ID
- 2022[07]
- Conditions
- Dental Implant
- Keywords
- robot-guided surgery, freehand, dental implant robot, accuracy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Qi YanUniversity, hospital or other
- Study start
- 7 Oct 2023 (estimated)
- Primary completion
- 7 Nov 2023 (estimated)
- Study completion
- 7 Dec 2023 (estimated)
- First posted
- 28 Sep 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.
We plan to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery, to evaluate the accuracy of implant in both groups.
Detailed description
Oral implants have become a widely used treatment modality for patients with missing or edentulous teeth. Previous studies have shown that implant accuracy is associated with implant success and long-term outcomes. Therefore, we plant to conduct this randomized clinical trial to compare the implant positional accuracy of robotic system-assisted implant surgery with that of conventional freehand implant surgery. Patients will be enrolled and randomly assigned to either an experimental group that underwent robotic surgery or a control group that underwent freehand surgery. By comparing the preoperative planned implant position with the actual postoperative implant position using CBCT, we will evaluate the accuracy of implant in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-guided | Experimental | Procedure: dental implant robotImplant placement by robot-guided based on a digital plan |
| Freehand surgery | Active comparator | Procedure: Freehand surgeryImplant placement by freehand based on a digital plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single missing teeth with adjacent and opposing healthy natural teeth;
- Healthy patients;
- Sufficient alveolar bone available for implant placement.
Key exclusion criteria (2 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...
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 |
|---|---|---|
| dental implant robotImplant placement will be navigated by a dental implant robot based on a digital plan. | Procedure or surgery | Robot-guided |
| Freehand surgeryImplant will be placed under freehand surgery. | 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.
1 secondary outcome
Surgery complication
Time frame: Immediately and seven 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 28 Sep 2023.
- Derived from this study: PubMed 42210518Luo Z, Zhou W, Wang M, Xu L, Du X, Cao Y, Song K. Accuracy, Efficiency, and Patient- and Surgeon-Reported Outcomes of Static Versus Robotic Computer-Assisted Implant Surgery: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 May 28. doi: 10.1111/clr.70138. Online ahead of print.
- 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.
Qi Yan, PhD principal investigator
School & Hospital of Stomatology, Wuhan University
Yufeng Zhang, PhD study chair
School & Hospital of Stomatology, Wuhan 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 dental implant robot and Freehand surgery in people with Dental Implant, run by Qi Yan 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 2 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 28 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. 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 Zhenqi Chen, MD (+86 13995544537, 1635156040@qq.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?
On the ClinicalTrials.gov record for NCT06059573, 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 28 Sep 2023.