Back to resultsAccuracy and Primary Stability of Straight and Tapered Implants in Immediate Implant Placement Using Dynamic Navigation
Primary Purpose
Tooth Diseases
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tapered Implants
Straight Implants
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Diseases
Eligibility Criteria
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.
Sites / Locations
- Shanghai Ninth People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
tapered implant
straight implant
Arm Description
Outcomes
Primary Outcome Measures
Accuracy
mm
Secondary Outcome Measures
Insetion torque value, ITV
to detect primary stability
Implant Stability Quotient, ISQ
to detect primary stability
Full Information
NCT ID
NCT04853121
First Posted
March 23, 2021
Last Updated
March 28, 2022
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT04853121
Brief Title
Accuracy and Primary Stability of Straight and Tapered Implants in Immediate Implant Placement Using Dynamic Navigation
Official Title
Accuracy and Primary Stability of Straight and Tapered Implants Placed Into Fresh Extraction Sockets Using Dynamic Navigation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tapered implant
Arm Type
Active Comparator
Arm Title
straight implant
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Tapered Implants
Intervention Description
Tapered Implants are placed in fresh socket via dynamic navigation
Intervention Type
Procedure
Intervention Name(s)
Straight Implants
Intervention Description
Straight Implants are placed in fresh socket via dynamic navigation
Primary Outcome Measure Information:
Title
Accuracy
Description
mm
Time Frame
one week
Secondary Outcome Measure Information:
Title
Insetion torque value, ITV
Description
to detect primary stability
Time Frame
surgery day
Title
Implant Stability Quotient, ISQ
Description
to detect primary stability
Time Frame
surgery day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
ZIP/Postal Code
200011
Country
China
12. IPD Sharing Statement
Learn more about this trial
Accuracy and Primary Stability of Straight and Tapered Implants in Immediate Implant Placement Using Dynamic Navigation
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