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

Tooth Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853121
• Other study ID #: SH9H-2020-T410-2
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: March 2022
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tooth Diseases

Intervention

Procedure:
• Tapered Implants
Tapered Implants are placed in fresh socket via dynamic navigation
• Straight Implants
Straight Implants are placed in fresh socket via dynamic navigation

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy	mm	one week
Secondary	Insetion torque value, ITV	to detect primary stability	surgery day
Secondary	Implant Stability Quotient, ISQ	to detect primary stability	surgery day