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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tooth Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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dynamic navigation

Dental implant placement using a dynamic navigation system

Group Type EXPERIMENTAL

dynamic navigation surgery

Intervention Type PROCEDURE

immediate implant placement using dynamic navigation

freehand

Dental implant placement using freehand technique

Group Type SHAM_COMPARATOR

freehand surgery

Intervention Type PROCEDURE

immediate implant placement using freehand surgery

Interventions

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dynamic navigation surgery

immediate implant placement using dynamic navigation

Intervention Type PROCEDURE

freehand surgery

immediate implant placement using freehand surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes