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

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ClinicalTrials.gov Identifier: NCT04853121
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Tooth Diseases Procedure: Tapered Implants Procedure: Straight Implants Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Accuracy and Primary Stability of Straight and Tapered Implants Placed Into Fresh Extraction Sockets Using Dynamic Navigation
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Disorders

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: tapered implant Procedure: Tapered Implants
Tapered Implants are placed in fresh socket via dynamic navigation
Placebo Comparator: straight implant Procedure: Straight Implants
Straight Implants are placed in fresh socket via dynamic navigation


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy [ Time Frame: one week ]
    mm


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853121


Contacts
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Contact: Junyu Shi, PhD 8653315299 sakyamuni_jin@163.com
Contact: Shimin Wei, DDS 86-19145635891 wssm@foxmail.com

Locations
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China
Shanghai Ninth People's Hospital Recruiting
Shanghai, China, 200011
Contact: Shimin Wei, MDS    008619145635891    wssm@foxmail.com   
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
More Information
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Responsible Party: Junyu Shi, Principal Investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT04853121    
Other Study ID Numbers: SH9H-2020-T410-2
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth Diseases
Stomatognathic Diseases