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

NCT04853121 | Completed DMC

• 1 other identifier: SH9H-2020-T410-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Diseases

Outcome Measures

Primary Outcomes (1)

• Accuracy

  mm

  one week

Secondary Outcomes (2)

• Insetion torque value, ITV

  surgery day

• Implant Stability Quotient, ISQ

  surgery day

Study Arms (2)

tapered implant

ACTIVE COMPARATOR

Procedure: Tapered Implants

straight implant

PLACEBO COMPARATOR

Procedure: Straight Implants

Interventions

Tapered Implants PROCEDURE

Tapered Implants are placed in fresh socket via dynamic navigation

tapered implant

Straight Implants PROCEDURE

Straight Implants are placed in fresh socket via dynamic navigation

straight implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, 200011, China

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 21, 2021
• Study Start: February 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CN (1)