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

Clinical Outcome of Two-piece Zirconia Implants in Immediate Implant Placement - a Prospective Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Immediate Implantation of Two-piece Zirconia Dental Implants
• Intervention / Treatment: Device: Implant Straumann® Pure Ceramic Two Piece Implant; Device: two-piece titanium implant Neoss® ProActive Tapered Implant

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Private practice Prof. Polansky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

Primary exclusion criteria are as follows:

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.

   Secondary exclusion criteria will be applied at surgical procedure:

6. loss of facial bone wall due to extraction procedure;
7. insufficient primary stability (less than 32Ncm insertion torque).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Implant Straumann® Pure Ceramic Two Piece Implant; Dental implants are placed directly after tooth extraction in the extraction socket.
Active Comparator: Two-piece titanium implants; Immediate dental implant placement will be performed by using the conventional two-piece titanium implant Neoss® ProActive Tapered Implant	Device: two-piece titanium implant Neoss® ProActive Tapered Implant; Dental implants are placed directly after tooth extraction in the extraction socket.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of PTV	Periotest value, Damping capacity assessment. For Periotest values, a customizable healing abutment will be inserted to assess damping capacity.	initial, 6 and 12 months after surgical procedure
Change of ISQ	Implant stability quotient. A transducer (smart-peg sensor) will be installed on the top of the implant to measure ISQ with resonance frequency analysis. ISQ will be measured from 4 different sites (facial, lingual, mesial, distal) and calculated as mean of measurements.	initial, 6 and 12 months after surgical procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of marginal bone loss	A single radiography in paralleling technique will be performed to measure marginal bone loss in millimeters (mm). Individualized x-ray holders will be used to ensure standardization and comparability in radiographic procedure.	6 and 12 months after surgical procedure
Change of PES	In the anterior region (4-4) the pink esthetic score (PES) (Fürhauser et al. 2005) will be used to evaluate the esthetic outcome of the soft tissue around the implant-supported single crowns by awarding seven points for the mesial and distal papilla, soft- tissue level, contour, colour, texture and alveolar process deficiency.	6 and 12 months after surgical procedure
Change of width of keratinized mucosa	The width of keratinized mucosa will be measured in millimetres at the narrowest distance between the mucosal margin and the mucogingival junction at the buccal aspect of the implant using Lugol ́s iodine solution.	initial, 12 months after surgical procedure
Change of BOP	Bleeding on probing will be recorded as positive (BOP+) when bleeding of the peri-implant mucosa is detected at implant (tooth) site-level after probing depth assessment within periodontal status.	initial, 6 and 12 months after surgical procedure
Gingival biotype	The tissue phenotype/gingival biotype will be classified at first visit with a conventional periodontal probe. Phenotype will be classified as thin, if the outline of the underlying probe can be seen shining through the buccal mucosa and as thick phenotype, if not.	initial
Mean insertion time	Time of implant insertion in seconds (sec).	at time of surgery
Change of PROM	Patient related outcome measures. Patients ́ oral-health related quality of life will be assessed before and 12 months after implant therapy by using a 14-point standardized questionnaire (OHIP-14).	initial, 12 months after surgical procedure
Complications - biological	Appearance of biological complications will be recorded in writing. Biological implant complications present the inflammatory reactions on peri-implant tissues, including peri-implant mucositis, peri-implantitis and implant loss.	at time of surgical procedure, 2 weeks, 6 months and 12 months after surgical procedure
Complications - biological	Appearance of biological complications will be recorded in writing. Biological implant complications present the inflammatory reactions on peri-implant tissues, including peri-implant mucositis, peri-implantitis and implant loss.	at time of surgical procedure
Complications - biological	Appearance of biological complications will be recorded in writing. Biological implant complications present the inflammatory reactions on peri-implant tissues, including peri-implant mucositis, peri-implantitis and implant loss.	2 weeks
Complications - biological	Appearance of biological complications will be recorded in writing. Biological implant complications present the inflammatory reactions on peri-implant tissues, including peri-implant mucositis, peri-implantitis and implant loss.	6 months
Complications - biological	Appearance of biological complications will be recorded in writing. Biological implant complications present the inflammatory reactions on peri-implant tissues, including peri-implant mucositis, peri-implantitis and implant loss.	12 months
Complications - technical	Appearance of technical complications will be recorded in writing. Technical complications as abutment screw fractures, fractures or chipping of prosthetics may appear due to biomechanical overloading and will be recorded.	at time of surgical procedure
Complications - technical	Appearance of technical complications will be recorded in writing. Technical complications as abutment screw fractures, fractures or chipping of prosthetics may appear due to biomechanical overloading and will be recorded.	2 weeks
Complications - technical	Appearance of technical complications will be recorded in writing. Technical complications as abutment screw fractures, fractures or chipping of prosthetics may appear due to biomechanical overloading and will be recorded.	6 months
Complications - technical	Appearance of technical complications will be recorded in writing. Technical complications as abutment screw fractures, fractures or chipping of prosthetics may appear due to biomechanical overloading and will be recorded.	12 months after surgical procedure
Complications - esthetic	Appearance of esthetic complications will be recorded in writing. Gingival recession or lack of interdental papillae account for implant esthetic complications and will be recorded.	at time of surgical procedure
Complications - esthetic	Appearance of esthetic complications will be recorded in writing. Gingival recession or lack of interdental papillae account for implant esthetic complications and will be recorded.	2 weeks
Complications - esthetic	Appearance of esthetic complications will be recorded in writing. Gingival recession or lack of interdental papillae account for implant esthetic complications and will be recorded.	6 months
Complications - esthetic	Appearance of esthetic complications will be recorded in writing. Gingival recession or lack of interdental papillae account for implant esthetic complications and will be recorded.	12 months after surgical procedure

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Raoul Polansky, DMD, Department of Dentistry and Oral Health, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): December 12, 2025
• Study Completion (Actual): December 12, 2025

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Osseointegration; Prospective Studies; Dental Implants; Patient Reported Outcome Measures; Esthetics; Resonance Frequency Analysis; zirconium oxide
• Other Study ID Numbers: IIP Ti Zr

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No