Clinical trial NCT05892406: Accuracy of Dental Implant Position Robotic Assistance, Dynamic Navigation, or Static Guide?
Official title: 3 Dimensional Accuracy of Dental Implant Placement: Randomised Controlled Trial Comparing Robotic Assistance, Dynamic Navigation, and Static Guide
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implant
Keywords: robotic surgery
dynamic surgical navigation
3D printed static guide
Accuracy
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. There are 3 available methods to improve implant position according to a digitally constructed prosthetically guided plan: the use of a 3D printed static guide, the use of a dynamic navigation system or the use of a robotic system. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction among three methods of digital guidance: the use of a 3D printed static guide, dynamic navigation, and robotic assisted 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 three 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 follow-up scan taken at the end of the 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. There are 3 available methods to improve implant position according to a digitally constructed prosthetically guided plan: the use of a 3D printed static guide, the use of a dynamic navigation system or the use of a robotic system. The goal of this randomized controlled trial is to compare the positional implant accuracy, the surgical time, and patient satisfaction among three methods of digital guidance: the use of a 3D printed static guide, dynamic navigation, and robotic assisted 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 three 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 follow-up scan taken at the end of the surgery. Platform deviation will be measured digitally. Subjects will be followed up for one year to assess both patient reported and professional outcomes and associate them with the precision of implant position.

Eligibility criteria: Inclusion Criteria:

* Patient with a single missing tooth, 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 systematic diseases/conditions that are contradictions to dental implant treatment; inability or unwillingness of individual to give written informed consent; inability of follow-up according to the protocol.

Primary outcomes:
measure: Implant positional accuracy
timeFrame: Immediately after surgery
measure: Peri-implant soft tissue health
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Surgery time
timeFrame: intraoperative
measure: Pain perception
timeFrame: Immediately after surgery
measure: Pain perception
timeFrame: 7 days after surgery
measure: Patient preference
timeFrame: Immediately after surgery
measure: Surgeon preference
timeFrame: Immediately after surgery
measure: Esthetics of the restoration
timeFrame: 12-months follow-up after delivery of crown
measure: Cytokine concentrations in PISF
timeFrame: 12-months follow-up after delivery of crown
measure: Submarginal microbiome
timeFrame: 12-months follow-up after delivery of crown
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Oral and Maxillofacial Implantology
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Perio-Implant Innovation Center
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Maurizio Tonetti, PhD
role: PRINCIPAL_INVESTIGATOR
References: