Accuracy of Dental Implant Placement Using a Collaborative Surgery Robot

Shanghai Jiao Tong University

Status: Active, not recruiting

Conditions: Dental Implant

Treatments: Procedure: Robot system; Procedure: Freehand surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05919862

SH9H-2023-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Robot system

Experimental group

Description:

Prosthetically guided Implant placement utilising robotic surgery based on a digital plan.

Treatment:

Procedure: Robot system

Freehand surgery

Sham Comparator group

Description:

Freehand implant placement by experienced surgeon.

Treatment:

Procedure: Freehand surgery