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Clinical Trials/NCT05919862
NCT05919862Active, not recruitingNot Applicable

Three-dimensional Positional Accuracy of Dental Implant Placement Using a Haptic and Machine Vision Controlled Collaborative Surgery Robot: a Pilot Randomized Controlled Trial

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 site in 1 country20 target enrollmentStarted: June 16, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Implant positional accuracy

Study Overview

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

Peri-implant soft tissue health

Time Frame: 12 month follow-up

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

Secondary Outcomes

  • Local integrity of the alveolar bone(Immediately after surgery)
  • Pain perception(immediately after surgery, and 1 to 7 days after surgery)
  • Cytokine concentrations in PISF(12-months follow-up after delivery of crown)
  • Submarginal microbiome(12-months follow-up after delivery of crown)
  • Discomfort perception(During surgery)
  • Esthetics of the restoration(12-months follow-up after delivery of crown)

Investigators

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maurizio Tonetti

Professor

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

Study Sites (1)

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