A post market multi-center prospective study of the Grant Dental Technology Corporation (GDTC) Proximerge™ Implant System

Grant Dental Technology Corporation (USA)0 个研究点目标入组 40 人开始时间: 2013年10月10日最近更新: 2015年1月13日

试验速览

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•The enrollment population for this clinical study will be selected from subjects scheduled to undergo an elective posterior maxilla or mandibular implant placement to restore a missing posterior tooth. A potential subject will be included in the study if he/she meets all of the following inclusion criteria:
•1. At least 25 years of age, either sex
•2. Demonstrate adequate oral hygiene (defined as an average Modified Sulcus Bleeding Index of = 1 and an average Modified Plaque Index of = 1)
•3. The location of the proposed implant must be a bounded edentulous space
•4. Bone Quality Index (BQI) of Type II (D2) or III (D3) bone
•4.1. Type II (D2) bone is defined as thick cortical bone with marrow cavity or
•4.2. Type III (D3) bone is defined as thin cortical bone with dense trabecular bone of good strength
•5. In the opinion of the investigator, demonstrate absence of any medical conditions, psychological illness, or social conditions that may potentially impact the safety and welfare of the subject or a favorable outcome with the implant (uncontrolled diabetes, malignancies, alcoholism, drug abuses, non-permanent housing, incarceration, etc.)
•6. Willingness, ability and commitment to comply with all requirements for the full length of the study
•7. Provided written informed consent to participate in the study signed by the subject or a legal representative

•A potential subject will be excluded from the study if he/she meets any of the following criteria:
•1. Inadequate bone volume to accommodate the planned endosseous dental implant. Inadequate bone volume defined as edentulous space dimensions unable to accommodate implant dimensions of <6.5 mm ridge width (facial-lingual), <8 mm in the mesial to distal dimension, and/or <10 mm in implant length (i.e. 9 mm facial-lingual, 11 mesiodistal, 12 mm depth)
•2. Active periodontal infections or untreated periodontitis
•3. History of radiation treatments to the head and/or neck
•4. Potential need for post implant bone grafting at the implant recipient site or previous bone grafting within six months due to inadequate bone volume
•5. History of parafunctions, (i.e. severe bruxing or clenching habits)
•6. Active systemic infection or any other health condition that would preclude elective surgery
•7. A tooth extraction at the implant site within the previous two months
•8. Presence of local inflammation or mucosal diseases such as lichen planus
•9. Subjects with a history of hematologic disorders or currently taking warfarin, dabigatran or other similar oral anticoagulants
•10. History of intravenous (IV)-based bisphosphonates use
•11. Subjects not willing to provide informed consent
•12. Pregnancy

发起方

Grant Dental Technology Corporation (USA)