Accuracy and Primary Stability in Immediate Implant Placement: Dynamic Navigation Versus Freehand
Primary Purpose
Tooth Diseases
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dynamic navigation surgery
freehand surgery
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Diseases
Eligibility Criteria
Inclusion Criteria:
- ≥18 years old and in good health;
- The maxillary incisor that cannot be retained due to non-periodontitis;
- The buccal bone plate is complete;
- No acute infection;
- The extraction socket have at least 3-5 mm apical bone.
Exclusion Criteria:
- General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids);
- Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy);
- Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm;
- Heavy smokers or previous heavy smoking history (quit smoking time <5 years or> 20 cigarettes per day);
- Refuse to participate in this trial.
Sites / Locations
- Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
- Department of Oral and Maxillofacial Implantology
- Shanghai Ninth People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
dynamic navigation
freehand
Arm Description
Dental implant placement using a dynamic navigation system
Dental implant placement using freehand technique
Outcomes
Primary Outcome Measures
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.
Peri-implant soft tissue health
Assessment of tissue health according to the definition of the 2017 International Classification. Berglundh et al.
Secondary Outcome Measures
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.
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.
Esthetic appearance of the dental crown
PES-WES Score assessed using the Belser criteria
Patient satisfaction
Assessed using a visual analogue scale (VAS=100mm, with 0=completely dissatisfied and 100 completely satisfied).
Peri-implant sulcus fluid Inflammation
Cytokine concentrations determined by multiplex ELISA
Buccal bone changes
Measurements performed on post-operative CBCT taken for routine follow-up
Implant microbiome
16S microbiome analysis performed on submarginal biofilm taken with a sterile paper point
Full Information
NCT ID
NCT04999956
First Posted
July 29, 2021
Last Updated
June 14, 2023
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT04999956
Brief Title
Accuracy and Primary Stability in Immediate Implant Placement: Dynamic Navigation Versus Freehand
Official Title
Accuracy and Primary Stability in Immediate Implant Placement Using Dynamic Navigation or Freehand
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dynamic navigation
Arm Type
Experimental
Arm Description
Dental implant placement using a dynamic navigation system
Arm Title
freehand
Arm Type
Sham Comparator
Arm Description
Dental implant placement using freehand technique
Intervention Type
Procedure
Intervention Name(s)
dynamic navigation surgery
Intervention Description
immediate implant placement using dynamic navigation
Intervention Type
Procedure
Intervention Name(s)
freehand surgery
Intervention Description
immediate implant placement using freehand surgery
Primary Outcome Measure Information:
Title
Accuracy
Description
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
Title
Peri-implant soft tissue health
Description
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
Secondary Outcome Measure Information:
Title
Insetion torque value (ITV)
Description
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
Title
Implant Stability Quotient (ISQ)
Description
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
Title
Esthetic appearance of the dental crown
Description
PES-WES Score assessed using the Belser criteria
Time Frame
12-months follow-up after delivery of the crown
Title
Patient satisfaction
Description
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
Title
Peri-implant sulcus fluid Inflammation
Description
Cytokine concentrations determined by multiplex ELISA
Time Frame
12-months follow-up after delivery of crown
Title
Buccal bone changes
Description
Measurements performed on post-operative CBCT taken for routine follow-up
Time Frame
12-months follow-up after delivery of crown
Title
Implant microbiome
Description
16S microbiome analysis performed on submarginal biofilm taken with a sterile paper point
Time Frame
12-months follow-up after delivery of crown
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
≥18 years old and in good health;
The maxillary incisor that cannot be retained due to non-periodontitis;
The buccal bone plate is complete;
No acute infection;
The extraction socket have at least 3-5 mm apical bone.
Exclusion Criteria:
General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids);
Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy);
Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm;
Heavy smokers or previous heavy smoking history (quit smoking time <5 years or> 20 cigarettes per day);
Refuse to participate in this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junyu Shi, PhD
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Department of Oral and Maxillofacial Implantology
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Accuracy and Primary Stability in Immediate Implant Placement: Dynamic Navigation Versus Freehand
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