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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Active, not recruiting

Conditions

Tooth Diseases

Treatments

Procedure: dynamic navigation surgery
Procedure: freehand surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04999956
SH9H-2020-T122-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups

dynamic navigation
Experimental group
Description:
Dental implant placement using a dynamic navigation system
Treatment:
Procedure: dynamic navigation surgery
freehand
Sham Comparator group
Description:
Dental implant placement using freehand technique
Treatment:
Procedure: freehand surgery

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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