Anthogyr Axiom Tissue-Level implants and corresponding Multi-Unit abutments recently enriched the available product range for dental surgeons. This Post-Market Clinical Follow-Up study aims at confirming the safety and performance of these products. The comparison with similar Anthogyr Axiom Bone-level implants will provide additional information on the effect of platform-switching in bone level maintenance for single and two-piece design at the implant level.
This is a multicenter, comparative, prospective, randomized, controlled, post-market clinical follow-up (PMCF) study. The total study duration for each patient should be 3 years. Anthogyr Axiom TL and BL REG and corresponding Multi-Unit abutments will be placed in healed bone crests in the mandible or maxilla for multiple teeth replacement, followed by a provisional prosthesis immediately loaded, if the patient needs a provisional. In total 8 visits per patient are scheduled in this study Implant and prosthesis survival, success, bone level changes, patient reported outcome, soft tissue assessment and adverse events (AEs) will be assessed. The investigational devices are CE-(Conformité Européenne, meaning European Conformity) marked product. 3 centers will participate in Spain and Portugal. The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155 and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Anthogyr AXIOM TL Reg will be placed in healed bone crests in the mandible or maxilla for multiple teeth replacement, followed by a provisional prosthesis immediately loaded, if the patient needs a provisional. In each case, the MU abutment will be placed immediately after implant placement. Multi-Unit abutments are used to fix the prosthesis
Axiom BL Reg implants will be placed in healed bone crests in the mandible or maxilla for multiple teeth replacement, followed by a provisional prosthesis immediately loaded, if the patient needs a provisional. In each case, the MU abutment will be placed immediately after implant placement. Multi-Unit abutments are used to fix the prosthesis
Faculdade de Medicina Dentária da Universidade do Porto
Porto, Portugal
Universidad International de Catalunya
Barcelona, Spain
Universidad de Santiago de Compostela
Santiago de Compostela, Spain
Marginal Bone Level Change
Change in crestal bone level measured by analysis of standardized peri-apical xrays \[mm\].
Time frame: 6 months,12 months, and 3 years after loading
Implant survival
A surviving implant is an implant that is in place at the time of evaluation.
Time frame: 6 months,12 months, and 3 years after loading
Prosthesis Survival
a surviving prosthesis is a prosthesis that is not broken at the time of evaluation.
Time frame: 6 months,12 months, and 3 years after prosthesis placement
14 item Oral Health Impact Profile (OHIP-14)
he 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: screening visit, 6, 12 months and 3 years after loading
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