Clinical Outcome of Two-piece Zirconia Implants in Immediate Implant Placement - a Prospective Randomized Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Implant Straumann® Pure Ceramic Two Piece Implant
- Conditions
- Immediate Implantation of Two-piece Zirconia Dental Implants
- Sponsor
- Medical University of Graz
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Change of ISQ
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
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;
- •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).
Arms & Interventions
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
Intervention: Implant Straumann® Pure Ceramic Two Piece Implant
Two-piece titanium implants
Immediate dental implant placement will be performed by using the conventional two-piece titanium implant Neoss® ProActive Tapered Implant
Intervention: two-piece titanium implant Neoss® ProActive Tapered Implant
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Change of BOP(initial, 6 and 12 months after surgical procedure)
- Mean insertion time(at time of surgery)
- Complications - esthetic(12 months after surgical procedure)
- Change of marginal bone loss(6 and 12 months after surgical procedure)
- Change of PES(6 and 12 months after surgical procedure)
- Complications - biological(12 months)
- Complications - technical(12 months after surgical procedure)
- Change of PROM(initial, 12 months after surgical procedure)
- Change of width of keratinized mucosa(initial, 12 months after surgical procedure)
- Gingival biotype(initial)
- Complications - biological(at time of surgical procedure, 2 weeks, 6 months and 12 months after surgical procedure)
- Complications - biological(at time of surgical procedure)
- Complications - biological(2 weeks)
- Complications - biological(6 months)
- Complications - technical(at time of surgical procedure)
- Complications - technical(2 weeks)
- Complications - technical(6 months)
- Complications - esthetic(at time of surgical procedure)
- Complications - esthetic(2 weeks)
- Complications - esthetic(6 months)