Immediate Implantation of Two-piece Zirconia Dental Implants
Conditions
Keywords
zirconium oxide, Dental Implants, Prospective Studies, Osseointegration, Resonance Frequency Analysis, Patient Reported Outcome Measures, Esthetics
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.
Interventions
DEVICEImplant Straumann® Pure Ceramic Two Piece Implant
Dental implants are placed directly after tooth extraction in the extraction socket.
DEVICEtwo-piece titanium implant Neoss® ProActive Tapered Implant
Dental implants are placed directly after tooth extraction in the extraction socket.
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Masking procedures are only applicable for the outcomes assessor. Due to the different colors of the compared implants, blinding procedures are not applicable for the investigator or the participants.
Intervention model description
prospective controlled randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Mean insertion time | at time of surgery | Time of implant insertion in seconds (sec). |
| 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). |
| Complications - biological | 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. |
| Complications - technical | 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. |
| Complications - esthetic | 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. |
Countries
Austria
Contacts
PRINCIPAL_INVESTIGATORRaoul Polansky, DMD
Department of Dentistry and Oral Health, Medical University of Graz
Outcome results
None listed