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Completed

NCT Number: NCT05369299

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

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.

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Key information

Conditions

Immediate Implantation of Two-piece Zirconia Dental Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private practice Prof. Polansky

Graz, Styria, 8010, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • good oral hygiene standard;
  • good general health;
  • 18 years or older;
  • non-smokers;
  • presence of single-tooth or multiple gaps in the mandible or the maxilla;
  • intact facial bone wall;
  • sufficient bone volume to support an implant of at least 10 mm length.
  • Teeth with removable periapical lesions are included.

Exclusion criteria

Primary exclusion criteria are as follows:

  • parafunctional habits;
  • active periodontitis;
  • smoking;
  • pregnancy;
  • 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:

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

Treatment and study plan

Implant Straumann® Pure Ceramic Two Piece Implant

Device

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

two-piece titanium implant Neoss® ProActive Tapered Implant

Device

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

Primary outcomes

  1. Change of PTV

    Time frame: initial, 6 and 12 months after surgical procedure

    Periotest value, Damping capacity assessment. For Periotest values, a customizable healing abutment will be inserted to assess damping capacity.

  2. Change of ISQ

    Time frame: initial, 6 and 12 months after surgical procedure

    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.

Secondary outcomes

  1. Change of marginal bone loss

    Time frame: 6 and 12 months after surgical procedure

    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.

  2. Change of PES

    Time frame: 6 and 12 months after surgical procedure

    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.

  3. Change of width of keratinized mucosa

    Time frame: initial, 12 months after surgical procedure

    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.

  4. Change of BOP

    Time frame: initial, 6 and 12 months after surgical procedure

    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.

  5. Gingival biotype

    Time frame: initial

    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.

  6. Mean insertion time

    Time frame: at time of surgery

    Time of implant insertion in seconds (sec).

  7. Change of PROM

    Time frame: initial, 12 months after surgical procedure

    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).

  8. Complications - biological

    Time frame: at time of surgical procedure, 2 weeks, 6 months and 12 months after surgical procedure

    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.

  9. Complications - biological

    Time frame: at time of surgical procedure

    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.

  10. Complications - biological

    Time frame: 2 weeks

    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.

  11. Complications - biological

    Time frame: 6 months

    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. Complications - biological

    Time frame: 12 months

    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.

  13. Complications - technical

    Time frame: at time of surgical procedure

    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.

  14. Complications - technical

    Time frame: 2 weeks

    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.

  15. Complications - technical

    Time frame: 6 months

    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.

  16. Complications - technical

    Time frame: 12 months after surgical procedure

    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.

  17. Complications - esthetic

    Time frame: at time of surgical procedure

    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.

  18. Complications - esthetic

    Time frame: 2 weeks

    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.

  19. Complications - esthetic

    Time frame: 6 months

    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.

  20. Complications - esthetic

    Time frame: 12 months after surgical procedure

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 11, 2022
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.