Clinical trial NCT04999956: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Diseases
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy
timeFrame: before surgery to after surgery one week
measure: Peri-implant soft tissue health
timeFrame: 12-months follow-up after delivery of crown
Secondary outcomes:
measure: Insetion torque value (ITV)
timeFrame: surgery day
measure: Implant Stability Quotient (ISQ)
timeFrame: surgery day
measure: Esthetic appearance of the dental crown
timeFrame: 12-months follow-up after delivery of the crown
measure: Patient satisfaction
timeFrame: 12-months follow-up after delivery of crown
measure: Peri-implant sulcus fluid Inflammation
timeFrame: 12-months follow-up after delivery of crown
measure: Buccal bone changes
timeFrame: 12-months follow-up after delivery of crown
measure: Implant microbiome
timeFrame: 12-months follow-up after delivery of crown
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Oral and Maxillo-facial Implantology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Department of Oral and Maxillofacial Implantology
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Junyu Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References: