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NCT Number: NCT04853121

Accuracy and Primary Stability of Straight and Tapered Implants in Immediate Implant Placement Using Dynamic Navigation

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 a reported better implant positioning. There are two main choices of implant macrogeometry: straight and tapered implants. One feature of implant design that may influence implants' accuracy is the taper of the implant body. However, their exact role is still needed to be investigated further. Besides, implant macrogeometry may influence primary stability, which is a prerequisite in achieving osseointegration. Therefore, we designed a randomized controlled clinical trial study to verify the clinical efficacy of the implant macrogeometry by comparing straight implants with tapered implants in immediate implant placement using dynamic navigation.

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Key information

Conditions

Tooth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Ninth People's Hospital

Shanghai, 200011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tapered Implants

Procedure

Tapered Implants are placed in fresh socket via dynamic navigation

Straight Implants

Procedure

Straight Implants are placed in fresh socket via dynamic navigation

Primary outcomes

  1. Accuracy

    Time frame: one week

    mm

Secondary outcomes

  1. Insetion torque value, ITV

    Time frame: surgery day

    to detect primary stability

  2. Implant Stability Quotient, ISQ

    Time frame: surgery day

    to detect primary stability

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Registry information

Official study title

Accuracy and Primary Stability of Straight and Tapered Implants Placed Into Fresh Extraction Sockets Using Dynamic Navigation

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 21, 2021
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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