Single or multiple dental prosthetic restorations Oral Health
Conditions
Interventions
A post-marketing clinical study designed to demonstrate safety and performance of the Proximerge™ Implant System.
The device used in this study is a CE marked dental implant that is used as standard
Sponsors
Grant Dental Technology Corporation (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the amount of bone loss at 6 months after the time of implant using the Proximerge™ Implant System. The performance goals based on literature is less than 1.5 mm bone loss at 6 months. The primary analysis will be a one sample T-test (two-sided) to determine if the bone loss is significantly different than the performance goal of 1.50 mm at 6 months. The primary hypothesis to be tested is: H0: PF = µT vs. H1: PF ? µT, where PF is the performance goal of 1.50 mm and µT is the population mean bone loss using Proximerge™ Implant System. The not equal sign is used because hypothesis testing is two-sided. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparative measurement between the Proximerge™ Implant System and a pre-determined performance goal (1.50 mm) of the amount of bone loss at 3, 9, 12, 18 and 24 months after the final crown is loaded. 2. Evaluation of implant ideal clinical condition based on the International Congress of Oral Implantologists (ICOI) Pisa Implant Quality Health Scale at 3, 6, 9, 12, 18 and 24 months after the final crown is loaded. 3. Evaluation of implant success based on the Implant-to-Crown Success Criteria at 3, 6, 9, 12, 18 and 24 months after the final crown is loaded. 4. Duration of implant success based the ICOI Pisa Implant Quality Health Scare (failure) 5. Evaluation of implant mobility (yes/no) and bone integrity (D5 or not D5) at 3, 6, 9, 12, 18 and 24 months after the final crown is loaded with the Proximerge™ Implant System. 6. Evaluation of dental implant associated peri-implant soft tissue health (bleeding index, plaque index, probe depth), at 3, 6, 9, 12, 18, and 24 months after the final crown is loaded with the Proximerge™ Implant System. 7. Evaluation of post market device related safety vigilance reporting. 8. Evaluation of all Unanticipated Adverse Device Effects (UADEs) including but not limited to those that may be related to toxicity from the device. 9. Evaluation of all Serious Adverse Events (SAEs) incurring during the study. | — |
Countries
United Kingdom
Outcome results
None listed