Evaluation of Survival and Success Rates of Zirzonia Dental Implants

NCT ID: NCT05105113

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2024-12-01

Brief Summary

Survival and success rates of Zirconia dental implants compared with Titanium implants (Two-Piece Zirconia implants)

Detailed Description

In the last three decades the use of dental implants to support oral rehabilitation has become a common treatment in dentistry and orthopedics.

The implants are made of titanium alloy and have shown high safety and effectiveness.

However, the gray color of the implant may be reflected through the gums and impair aesthetics in the areas of the front of the mouth.

Against this background, in recent years, implant companies have developed zirconia implants, which are white in color.

Studies have shown an aesthetic advantage for zirconia implants and zirconia structures compared to titanium when placed in an aesthetic area in patients with thin gums.

Zirconia implants are resistant to high forces and like titanium implants they undergo osteointegration into the bone, another study in dogs demonstrated an improvement in the soft and hard tissue integration in zirconia implants compared to titanium. In addition to the aesthetic benefit, zirconia implants may have an advantage in a less inflammatory response in the tissues surrounding the implant. In recent years, a number of studies have been published showing detachment of titanium particles from titanium implants which cause an inflammatory response and the absorption of supporting bone around the implant. In addition, several laboratory studies have shown an advantage for zirconia implants in terms of bacterial adsorption to the surface of the implant compared to titanium implants. Studies have been found that show higher pathogenic bacterial adsorption to titanium compared to zirconia.

TavMedical was established in 1975 and mainly specializes in the production, development and marketing of consumable medical products.

In 2011 the company began to develop dental products including implants, parts and utensils.

The company specializes mainly in zirconia dental products. Titanium implants are common and well-known implants and the company focuses its activities on promoting zirconia implants, which constitute a significant differentiation from the titanium implants currently sold in the world.

The purpose of developing zirconia dental implants is to introduce zirconia implants as a preferred alternative to the dental implants currently sold from titanium.

Also, improving the implant treatments currently offered by providing an alternative with high aesthetic results. Patients in the modern age are characterized by a high awareness of their health condition and their demand for treatment with high aesthetic results.

The natural tooth and being a metal-free material adapted to a growing trend all over the world.

Research Hypothesis - Based on the literature, the success rate and survival of zirconia implants is similar to titanium implants and stands at about 95% chance of survival.

Thus differences in the survival and success of titanium implants compared to zirconia are not expected.

Clinical inflammation markers and low-level pro-inflammatory cytokines were found around zirconia implants compared to titanium implants.

Aim of the study - Comparison of survival, success and signs of inflammation of zirconia implants compared to titanium implants.

Conditions

Dental Implantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zirconia dental implant

Patients treated with zirconia dental implant (Tav-dental) to replace missing tooth

Group Type: EXPERIMENTAL

Zirconia dental implant installation surgery

Intervention Type: PROCEDURE

Dental implant installation surgery using zirconia one-piece implant (Tav-dental)

Interventions

Zirconia dental implant installation surgery

Dental implant installation surgery using zirconia one-piece implant (Tav-dental)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subject must have voluntarily signed the informed consent form.
• Male or female patient aged ≥18 Years old.
• Replacing a missing tooth by use of implant supported restoration in implantation sites that do not require extensive augmentation procedure.
• Good primary implant stability at implant placement (35N and more).
• Compliance with study schedules and arrival at study visits.

Exclusion Criteria

• Pregnant or lactating women.
• Imbalance diabetes.
• Head and neck rediation therapy.
• Active Periodontal disease and caries.
• Patient in need of tooth extraction and immediat implantation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hadar Zigdon, DMD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Rambam Health Care Campus

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Hadar Zigdon, DMD

Role: CONTACT

h_zigdon@rambam.health.gov.il

9727772983

Eli Machtei, DMD

Role: CONTACT

machtei@rambam.health.gov.il

9727772983

Other Identifiers

0382-19 -RMB CTIL

Identifier Type: -

Identifier Source: org_study_id