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A prospective randomized controlled clinical study comparing the accuracy of robot-assisted versus Digit Surgical Guide-assisted Neoss dental implant placement

A prospective randomized controlled clinical study comparing the accuracy of robot-assisted versus Digit Surgical Guide-assisted Neoss dental implant placement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128537
Enrollment
Unknown
Registered
2026-07-22
Start date
2026-07-31
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects requiring single-tooth implant restoration

Interventions

Trial group:The implantation of dental implants is carried out using a robotic-assisted system, which includes intraoperative registration, alignment, drilling sequence and implant placement.
Control group:Implant placement is carried out using a digital dynamic guide system, which includes guide plate fixation, registration, real-time guidance for drilling and implant placement.

Sponsors

Hospital of Stomatology, SunYat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age range: 18 - 75 years old. Gender: Open to all. 2.Planned to perform single tooth implant restoration (for both the upper and lower jaws); 3.The preoperative imaging and clinical examination indicated that conventional implantation could be performed (without the need for a major bone augmentation surgery); 4.Be able to understand the research content and sign the informed consent form; 5.Postoperative follow-up and routine imaging examinations (with postoperative CBCT being the main routine) can be carried out as required.

Exclusion criteria

Exclusion criteria: 1.Uncontrolled systemic diseases affect bone healing (the researchers judged that factors such as significantly elevated HbA1c and immunosuppression were involved); 2.History of head and neck radiotherapy, significant abnormalities in bone metabolism; or history of using high-risk anti-osteoclastic drugs (judged by the investigator); 3.Pregnancy or lactation period; 4.Active oral infections or severe uncontrolled periodontal disease; 5.Requires complex bone augmentation procedures (such as maxillary sinus lift, block bone grafting, etc.) or other measures that significantly increase the complexity of the surgery (to reduce confounding factors); 6.Severe mouth opening restriction, inability to complete device registration/tracking, or those who cannot cooperate. 7.Other situations that the researchers consider not suitable for inclusion;

Design outcomes

Primary

MeasureTime frame
Angular Deviation;

Secondary

MeasureTime frame
Entry Point Deviation;Apical Deviation;Surgical Efficiency;Intraoperative System Events;Safety Outcomes;Patient-Reported Outcomes;Early Stability;

Countries

China

Contacts

Public ContactLi Zhipeng

Hospital of Stomatology, SunYat-sen University

implants@163.com+86 20 83862537

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026