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

NCT ID: NCT04853121

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tooth Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tapered implant

Group Type ACTIVE_COMPARATOR

Tapered Implants

Intervention Type PROCEDURE

Tapered Implants are placed in fresh socket via dynamic navigation

straight implant

Group Type PLACEBO_COMPARATOR

Straight Implants

Intervention Type PROCEDURE

Straight Implants are placed in fresh socket via dynamic navigation

Interventions

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Tapered Implants

Tapered Implants are placed in fresh socket via dynamic navigation

Intervention Type PROCEDURE

Straight Implants

Straight Implants are placed in fresh socket via dynamic navigation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Junyu Shi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Ninth People's Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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SH9H-2020-T410-2

Identifier Type: -

Identifier Source: org_study_id

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