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

March 28, 2022 updated by: Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Accuracy and Primary Stability of Straight and Tapered Implants Placed Into Fresh Extraction Sockets 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200011
        • Shanghai Ninth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: one week
mm
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insetion torque value, ITV
Time Frame: surgery day
to detect primary stability
surgery day
Implant Stability Quotient, ISQ
Time Frame: surgery day
to detect primary stability
surgery day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH9H-2020-T410-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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