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Exploring Clinical Implementation of Computer-assisted Implant Surgery Pathways: A Multi-center, multi-dimension assessment of Patient & Clinician Reported Outcomes, Learning Efficiency and Institutional Integration of dynamic and robotic CAIS

Computer-assisted Implant Surgery (CAIS): Exploring Pathways of Clinical Implementation. A Multi-center, multi-dimension assessment of Patient & Clinician Reported Outcomes, Learning Curve, Relative Efficiency index and Institutional Integration of dynamic and robotic CAIS

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260410006
Enrollment
180
Registered
2026-04-10
Start date
2026-08-01
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

Dental implant rehabilitation in partially or fully edentulous patients requiring implant placement, with focus on clinical implementation of computer assisted implant surgery workflows including dynamic navigation and robotic systems, addressing patient reported outcomes, surgeon workload and performance, learning curve, and workflow efficiency during implant surgery. Dental Implant Dental Implant Surgery Computer-assisted implant surgery Navigation dynamic Robotic Learning curve

Interventions

Enrolled surgeons will undergo standardised education and pre-clinical training in d-CAIS in all 5 centres, as developed in phase 1. Enrolled surgeons will conduct surgeries with the aid of d-CAIS
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
Dynamic CAIS,Robotic CAIS

Sponsors

Chulalongkorn University, Faculty of Dentistry
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: Operator Participants: Inclusion: - Postgraduate trainees in implant dentistry or related specialty training programs - Experience in freehand implant surgery (straightforward to intermediate cases) - No prior dynamic CAIS experience Exclusion: - Prior synamic/ robotic CAIS experience Patient Participants: Inclusion: -Healthy Adults (ASA I&II, >20 years old) requiring and suitable for rehabilitation with dental implants. -Suitable for implant placement using computer-assisted techniques according to clinical indication (single to multiple teeth missing) -Able to understand study information and provide written informed consent -Willing to comply with study procedures and follow-up

Exclusion criteria

Exclusion criteria: Exclusion: -Inability to provide informed consent -Medical contraindications to implant surgery according to local clinical guidelines -Uncontrolled systemic disease -Pregnancy -Severe psychiatric or psychological conditions affecting participation -Inability to comply with study procedures or follow-up

Design outcomes

Primary

MeasureTime frame
Domain 1a: Patient Reported Ouctomes and Patient Reported Experience Progressively throughout the study PROMs / PRE measures,Domain 1b: Objective assessment of patient experience measures Progressively throughout the study Assessment of Objective Patient Experience Measures,Domain 2a: Clinician Reported Ouctomes and Experience Progressively throughout the study CROMs / CRE measures,Domain 2b: Assessment of Clinician Performance Progressively throughout the study Objective Performance Measures,Domain 3a: Assessment of Procedure Efficiency Progressively throughout the study Intervention Specific Efficiency Outcomes Measures,Domain 3b: Assessment of Institution Efficiency Progressively throughout the study Institution Specific Efficiency Outcomes Measures

Secondary

MeasureTime frame
Assessment of Clinician Learning Curve end of the study Progressive assessment of Performance Outcomes Measures,Relative Efficiency Index end of the study Collective Assessment of outcomes measures per intervention,Patient-centred Efficiency index end of study Collective Assessment of PROMs/PRE outcomes measures per intervention,Clinician-centred Efficiency Index end of the study Collective Assessment of CROMs/CRE outcomes measures per intervention,Institution-centred Efficiency Index end of study Collective Assessment of institution related outcomes outcomes measures per intervention

Countries

Thailand

Contacts

Public ContactShengchi Fan

Chulalongkorn University

fanshengchi@outlook.com6622188664

Outcome results

None listed

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