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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT05369299
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-11
• Study Start: 2022-05-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two-piece titanium implants	two-piece titanium implant Neoss® ProActive Tapered Implant	Immediate dental implant placement will be performed by using the conventional two-piece titanium implant Neoss® ProActive Tapered Implant
Two-piece zirconia implants	Implant Straumann® Pure Ceramic Two Piece Implant	Immediate dental implant placement will be performed by using the new two-piece zirconia implant Straumann® Pure Ceramic Two Piece Implant

Primary Outcome Measures

Name	Time	Method
Change of ISQ	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.
Change of PTV	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.

Secondary Outcome Measures

Name	Time	Method
Change of BOP	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.
Mean insertion time	at time of surgery	Time of implant insertion in seconds (sec).
Complications - esthetic	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.
Change of marginal bone loss	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.
Change of PES	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.
Complications - biological	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.
Complications - technical	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.
Change of PROM	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).
Change of width of keratinized mucosa	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.
Gingival biotype	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.

Trial Locations

Locations (1)

Private practice Prof. Polansky; 🇦🇹 Graz, Styria, Austria