A post-market, multi-centre, prospective, open, randomized-controlled, non-inferiority clinical study to compare short-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow.
To compare short-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow. Post-market, multi-centre, prospective, open, randomized-controlled, non-inferiority clinical study investigating patients in need of dental implant therapy for single-tooth gap rehabilitation. The follow up time is1 year after final crown restoration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
The ceramic implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading after 4 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.
The titanium implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading after 4 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.
Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik
Düsseldorf, Germany
The University of Hong Kong, Prince Philip Dental Hospital
Hong Kong, Hong Kong
Implantology Institute
Lisbon, Portugal
Bone Level Change
Change in crestal bone level measured by analysis of standardized peri-apical xrays 12 months after loading \[mm\].
Time frame: 12 months after implant loading (final crown restoration)
Implant survival
Implant survival rates 3, 6 months and 1 year after loading: yes/no
Time frame: 12 months after loading.
14 item Oral Health Impact Profile (OHIP-14)
The local language version of the OPHIP-14 is a self-reported questionnaire that measures dysfunction, discomfort and disability attributed to oral conditions. The questionnaire focuses on seven dimensions of impact: Functional limitation; Pain; Psychological discomfort; Physical disability; Psychological disability; Social disability; Handicap. The patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4).
Time frame: 12 months after loading.
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