Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dynamic navigation | Experimental | Dental implant placement using a dynamic navigation system |
|
| freehand | Sham Comparator | Dental implant placement using freehand technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dynamic navigation surgery | Procedure | immediate implant placement using dynamic navigation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12-months follow-up after delivery of crown |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | surgery day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Junyu Shi, PhD | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University | Shanghai | Shanghai Municipality | 200011 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| freehand surgery | Procedure | immediate implant placement using freehand surgery |
|
| 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. |
| surgery day |
| Esthetic appearance of the dental crown | PES-WES Score assessed using the Belser criteria | 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). | 12-months follow-up after delivery of crown |
| Peri-implant sulcus fluid Inflammation | Cytokine concentrations determined by multiplex ELISA | 12-months follow-up after delivery of crown |
| Buccal bone changes | Measurements performed on post-operative CBCT taken for routine follow-up | 12-months follow-up after delivery of crown |
| Implant microbiome | 16S microbiome analysis performed on submarginal biofilm taken with a sterile paper point | 12-months follow-up after delivery of crown |
| Department of Oral and Maxillofacial Implantology | Shanghai | Shanghai Municipality | 200011 | China |
| Shanghai Ninth People's Hospital | Shanghai | Shanghai Municipality | 200011 | China |