Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters.
Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been reported better implant positioning. However, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. Besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. Therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. Patients will then be followed up one year after delivery of the crown to assess additional parameters. These will include the assessment of soft tissue inflammation, cytokine concentrations, microbiome, stability of the buccal bone plate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
immediate implant placement using dynamic navigation
immediate implant placement using freehand surgery
Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Department of Oral and Maxillofacial Implantology
Shanghai, Shanghai Municipality, China
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China
Accuracy
Taking cone-beam computed tomography (CBCT). The deviation between the planned implant and the actual implant were measured by Computer Assisted Dental Implant Precision System (Dcarer, Suzhou, China) as follows: (1) At least four feature points (like tooth cusps or bone pits) were selected in preoperative and postoperative CBCT for rough registration. (2) Feature surface circles in preoperative CBCT were selected, and then a mathematical algorithm displayed a similar feature surface circle in postoperative CBCT. The algorithm registered thousands of points in these two circles via conventional iso-surface thresholding technology. The software calculated registration error automatically. (3) Finally, the planned and actual implant were identified, and the deviation would be automatically calculated.
Time frame: before surgery to after surgery one week
Peri-implant soft tissue health
Assessment of tissue health according to the definition of the 2017 International Classification. Berglundh et al.
Time frame: 12-months follow-up after delivery of crown
Insetion torque value (ITV)
A general method to to detect primary stability roughly. The ITV were evaluated by a wrench (Straumann, Waldenburg, Switzerland) at the time of implant placement. The investigator record the number of scale. Being equal to or greater than 35N is a ideal primary stability.
Time frame: surgery day
Implant Stability Quotient (ISQ)
A device to detect primary stability precisely. A Smartpeg was screwed into each implant, and resonance frequency analysis (RFA) was performed using Osstell Mentor (Osstell/Integration Diagnostics, Goteborg, Sweden). ISQ were recorded in the buccal and the palatal directions three times and averaged. \<60 represents low stability; 60-70 represents medium stability; higher than 70 represents high stability.
Time frame: surgery day
Esthetic appearance of the dental crown
PES-WES Score assessed using the Belser criteria
Time frame: 12-months follow-up after delivery of the crown
Patient satisfaction
Assessed using a visual analogue scale (VAS=100mm, with 0=completely dissatisfied and 100 completely satisfied).
Time frame: 12-months follow-up after delivery of crown
Peri-implant sulcus fluid Inflammation
Cytokine concentrations determined by multiplex ELISA
Time frame: 12-months follow-up after delivery of crown
Buccal bone changes
Measurements performed on post-operative CBCT taken for routine follow-up
Time frame: 12-months follow-up after delivery of crown
Implant microbiome
16S microbiome analysis performed on submarginal biofilm taken with a sterile paper point
Time frame: 12-months follow-up after delivery of crown
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