Clinical Outcome of Two-piece Zirconia Implants in Immediate Implant Placement

NCT ID: NCT05369299

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-13
• Study Completion Date: 2025-12-12

Brief Summary

The purpose of the study is to test whether a two-piece zirconia implant is as reliable in the indication of immediate implant placement as a standard titanium implant.

Conditions

Immediate Implantation of Two-piece Zirconia Dental Implants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Two-piece zirconia implants

Immediate dental implant placement will be performed by using the new two-piece zirconia implant Straumann® Pure Ceramic Two Piece Implant

Group Type: EXPERIMENTAL

Implant Straumann® Pure Ceramic Two Piece Implant

Intervention Type: DEVICE

Dental implants are placed directly after tooth extraction in the extraction socket.

Two-piece titanium implants

Immediate dental implant placement will be performed by using the conventional two-piece titanium implant Neoss® ProActive Tapered Implant

Group Type: ACTIVE_COMPARATOR

two-piece titanium implant Neoss® ProActive Tapered Implant

Intervention Type: DEVICE

Dental implants are placed directly after tooth extraction in the extraction socket.

Interventions

Implant Straumann® Pure Ceramic Two Piece Implant

Dental implants are placed directly after tooth extraction in the extraction socket.

Intervention Type: DEVICE

two-piece titanium implant Neoss® ProActive Tapered Implant

Dental implants are placed directly after tooth extraction in the extraction socket.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Patients giving informed consent to participate in the clinical trial and fulfil the following criteria will be included in the investigation:

1. good oral hygiene standard;

2. good general health;

3. 18 years or older;

4. non-smokers;

5. presence of single-tooth or multiple gaps in the mandible or the maxilla;

6. intact facial bone wall;

7. sufficient bone volume to support an implant of at least 10 mm length.

8. Teeth with removable periapical lesions are included.

Exclusion Criteria

1. parafunctional habits;

2. active periodontitis;

3. smoking;

4. pregnancy;

5. acute or chronic medical conditions for which implant therapy has always been considered a contraindication: uncontrolled diabetes (HbA1c >8.0%), mucosal disease, untreated periodontitis, immunological disorders, active malignancy, alcoholism, condition after radiation therapy to the head and neck area and antiresorptive therapy.

6. loss of facial bone wall due to extraction procedure;

7. insufficient primary stability (less than 32Ncm insertion torque).

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

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raoul Polansky, DMD

Role: PRINCIPAL_INVESTIGATOR

Department of Dentistry and Oral Health, Medical University of Graz

Locations

Private practice Prof. Polansky

Graz, Styria, Austria

Countries

Austria

Other Identifiers

IIP Ti Zr

Identifier Type: -

Identifier Source: org_study_id