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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
A static guide will be designed and fabricated based on CBCT and intra-oral scan. Implant will be placed under the assistance of statistic guide through the whole procedure.
Implant will be placed under the assistance of dynamic navigation.
Implant will be placed under robotic arm and human collaboration.
Department of Oral and Maxillofacial Implantology
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Perio-Implant Innovation Center
Shanghai, Shanghai Municipality, China
RECRUITINGImplant positional accuracy
Implant accuracy will be measured as discrepancy between the digital plan and t actual position of the implant.
Time frame: Immediately after surgery
Peri-implant soft tissue health
Defined according to the peri-implant health case definition by Berglundh et al 2017 and the ID-COSM international consensus conference
Time frame: 12 month follow-up
Surgery time
Time needed for surgery procedure will be recorded from anaesthesia to connection of cover screw/healing abutment.
Time frame: intraoperative
Pain perception
Patient pain perception during surgery will be recorded using visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience) .
Time frame: Immediately after surgery
Pain perception
Patient pain perception after surgery will be recorded using visual analogue scale (VAS with range from 0 to 10 with 10 being the highest possible pain experience) .
Time frame: 7 days after surgery
Patient preference
Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option.
Time frame: Immediately after surgery
Surgeon preference
Assessed using a visual analogue scale (VAS, 100 mm, with 0=least desirable option and 100 = most desirable option.
Time frame: Immediately after surgery
Esthetics of the restoration
Assessed using the PES-WES scale as reported by Belser et al. with 0 being the worst and 14 the best value in the scale
Time frame: 12-months follow-up after delivery of crown
Cytokine concentrations in PISF
Cytokine concentration in peri-implant sulcus fluid assesed by MULTIPLEX ELISA of IL-1, TNFa, IL-6 with lower concentrations representing less inflammation.
Time frame: 12-months follow-up after delivery of crown
Submarginal microbiome
16S assessment of microbiome diversity (Shannon index) with greater diversity representing a more stable microbiome
Time frame: 12-months follow-up after delivery of crown
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