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

Not Applicable

Active, not recruiting

• Conditions: Tooth Diseases
• Interventions: Procedure: freehand surgery; Procedure: dynamic navigation surgery

• Registration Number: NCT04999956
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-07-29
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-11
• Primary Completion: 2021-12-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-18
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
freehand	freehand surgery	Dental implant placement using freehand technique
dynamic navigation	dynamic navigation surgery	Dental implant placement using a dynamic navigation system

Primary Outcome Measures

Name	Time	Method
Accuracy	before surgery to after surgery one week	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	12-months follow-up after delivery of crown	Assessment of tissue health according to the definition of the 2017 International Classification. Berglundh et al.

Secondary Outcome Measures

Name	Time	Method
Implant microbiome	12-months follow-up after delivery of crown	16S microbiome analysis performed on submarginal biofilm taken with a sterile paper point
Peri-implant sulcus fluid Inflammation	12-months follow-up after delivery of crown	Cytokine concentrations determined by multiplex ELISA
Buccal bone changes	12-months follow-up after delivery of crown	Measurements performed on post-operative CBCT taken for routine follow-up
Patient satisfaction	12-months follow-up after delivery of crown	Assessed using a visual analogue scale (VAS=100mm, with 0=completely dissatisfied and 100 completely satisfied).
Esthetic appearance of the dental crown	12-months follow-up after delivery of the crown	PES-WES Score assessed using the Belser criteria
Insetion torque value (ITV)	surgery day	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)	surgery day	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.

Trial Locations

Locations (3)

Department of Oral and Maxillofacial Implantology; 🇨🇳 Shanghai, Shanghai, China

Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China