herstel dentitie missing teeth partial edentulous
Conditions
Interventions
None listed
Sponsors
Gulje Mondzorg bv
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: For inclusion in the clinical investigation subjects must meet all of the following criteria: 1. Adult aged 18-75 years. 2. Willing and able to sign and date the informed consent form. 3. In need of an implant in position 16 to 26 or 36 to 46, and each subject can only receive one implant. 4. Deemed by the investigator as likely to present with an initially stable implant situation. 5. A stable occlusion, i.e. an opposing natural dentition, a crown, an implant-supported fixed or removable prosthesis, a partial removable prosthesis or a full denture. 6. An adjacent tooth (root with natural or artificial crown) or an implant-supported crown mesially and distally. Exemption: If the planned implant is in the first molar position, an edentulous space is accepted distally.
Exclusion criteria
Exclusion criteria: Exclusion criteria All exclusion criteria apply at inclusion with a final eligibility verification prior to implantation, but exclusion criteria number 4 also applies during the entire clinical investigation period. Any of the following is regarded as a criterion for exclusion from the clinical investigation: 1. Not willing to participate in the clinical investigation or not able to understand the content of the clinical investigation. 2. Unlikely to be able to comply with clinical investigation procedures according to investigator*s judgement. 3. Unable or unwilling to return for follow-up visits for a period of 5 years. 4. Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona. 5. Known allergy or hypersensitivity to titanium and/or stainless steel. 6. Uncontrolled pathological process in the oral cavity, e.g. untreated rampant caries and uncontrolled periodontal disease. 7. Uncontrolled para-functional habits, e.g. bruxism. 8. Current need of any Guided Bone Regeneration (GBR) procedure in the planned implant area (gap filling at immediate placement and soft tissue grafting are allowed). 9. Systemic or local disease or condition that would compromise post-operative healing and/ or osseointegration. 10. Immunosuppression, use of corticosteroids, per-os or intravenous bisphosphonate use, or any other medication such as anti-resorptive therapy or monoclonal antibodies that could compromise post-operative healing and/or osseointegration. 11. Any other condition that would make the subject unsuitable for participation, including but not limited to; * History of radiation therapy in the head and neck region. * History of chemotherapy within 5 years prior to surgery. * Present alcohol and/or drug abuse. * Ongoing psychiatric illness. * Current smoking/use of tobacco, including e-cigarettes. 12. Any ongoing disease that would make the subject unsuitable for participation, including but not limited to; * Recent myocardial infarction (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this clinical investigation is to evaluate implant survival rate 1 year after permanent restoration (PR), i.e. implant in place 1 year after PR, Yes/No. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to evaluate: * Implant survival rate 2, 3, 4 and 5 years after PR. * Implant stability at implant placement and at PR. * Insertion Torque Value (ITV) and torque build-up at implant placement. * The surgeon*s perception of implant stability and confidence at implant placement. * Maintenance of Marginal Bone Levels (MBL). * Condition of the periimplant mucosa (bleeding on probing (BoP), probing pocket depth (PPD) and plaque). * Implant success (adapted Albrektsson et al 19866). | — |
Countries
Netherlands
Outcome results
None listed