Accuracy and Primary Stability in Immediate Implant Placement: Dynamic Navigation Versus Freehand

Accuracy and Primary Stability in Immediate Implant Placement Using Dynamic Navigation or Freehand

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tooth Diseases
• Intervention / Treatment: Procedure: dynamic navigation surgery; Procedure: freehand surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital
    • Shanghai, Shanghai, China, 200011
      • Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
    • Shanghai, Shanghai, China, 200011
      • Department of Oral and Maxillofacial Implantology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. ≥18 years old and in good health;
2. The maxillary incisor that cannot be retained due to non-periodontitis;
3. The buccal bone plate is complete;
4. No acute infection;
5. The extraction socket have at least 3-5 mm apical bone.

Exclusion Criteria:

1. General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids);
2. Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy);
3. Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm;
4. Heavy smokers or previous heavy smoking history (quit smoking time <5 years or> 20 cigarettes per day);
5. Refuse to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dynamic navigation; Dental implant placement using a dynamic navigation system	Procedure: dynamic navigation surgery; immediate implant placement using dynamic navigation
Sham Comparator: freehand; Dental implant placement using freehand technique	Procedure: freehand surgery; immediate implant placement using freehand surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Principal Investigator: Junyu Shi, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Estimated): July 31, 2023

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases
• Other Study ID Numbers: SH9H-2020-T122-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No