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

Study Overview
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Brief Summary
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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.

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

Conditions
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Immediate Implantation of Two-piece Zirconia Dental Implants

Intervention / Treatment
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* Device: Implant Straumann® Pure Ceramic Two Piece Implant
* Device: two-piece titanium implant Neoss® ProActive Tapered Implant


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective controlled randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two-piece zirconia implants<br>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<br>* Dental implants are placed directly after tooth extraction in the extraction socket.<br>|
| Active Comparator: Two-piece titanium implants<br>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<br>* Dental implants are placed directly after tooth extraction in the extraction socket.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Reported Outcome Measures, Esthetics, Osseointegration, Resonance Frequency Analysis, zirconium oxide, Dental Implants, Prospective Studies