Accuracy of Dental Implant Placement Using a Collaborative Surgery Robot

NCT05919862 | Unknown DMC

• 1 other identifier: SH9H-2023-05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implant

Outcome Measures

Primary Outcomes (2)

• 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.

  Immediately after surgery

• Peri-implant soft tissue health

  Bleeding on probing and probing depth will be recorded, by probing gently around implant-supported restoration at six points: mesial-buccal, mid-buccal, distal-buccal, mesial-lingual, mid-lingual, and distal-lingual, using UNC-15 periodontal probe. This is defined according to the peri-implant health case definition by Berglundh et al 2017 and the ID-COSM international consensus conference

  12 month follow-up

Secondary Outcomes (6)

• Local integrity of the alveolar bone

  Immediately after surgery

• Discomfort perception

  During surgery

• Pain perception

  immediately after surgery, and 1 to 7 days after surgery

• Esthetics of the restoration

  12-months follow-up after delivery of crown

• Cytokine concentrations in PISF

  12-months follow-up after delivery of crown

Study Arms (2)

Robot system

EXPERIMENTAL

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

Procedure: Robot system

Freehand surgery

SHAM COMPARATOR

Freehand implant placement by experienced surgeon.

Procedure: Freehand surgery

Interventions

Robot system PROCEDURE

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

Robot system

Freehand surgery PROCEDURE

Freehand implant placement by experienced surgeon.

Freehand surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Department of Oral and Maxillofacial Implantology

Shanghai, Shanghai Municipality, 200011, China

Location

Study Officials

• Tonetti Maurizio, PhD

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: June 16, 2023
• Primary Completion: June 30, 2023
• Study Completion: November 30, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)