Partial Edentulism Clinical Trial
— TMELOfficial title:
A Randomized Controlled Multicenter Study of Trabecular Metal Dental Implants vs.Tapered Screw-Vent Dental Implants Loaded Early vs. Conventionally in the Maxilla and Mandible.
NCT number | NCT02158377 |
Other study ID # | CSU2011-08D |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | July 2020 |
Verified date | March 2022 |
Source | ZimVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized-controlled, multicenter study of Trabecular Metal (TM) and Tapered Screw-Vent (TSV) dental implants loaded early in maxillary and mandibular sites.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 2020 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Benefit from the implant and restoration 2. Provide a voluntarily signed Informed Consent 3. Must be 18 years or older 4. Have one or more edentulous area(s) in the posterior maxilla or mandible designated for an implant supported restoration 5. The implantation site must have a functional antagonist to obtain full occlusion. 6. Implants adjacent to planned site of implantation should have been in function for at least 1 year. 7. The site intended for implant placement should have healed for at least 4 months from the time of extraction or at least 6 months from any other bone augmentation procedures. 8. The site intended for implant placement should have adequate bone volume to support an implant without the need for augmentation except for minor dehiscence (limited to a vertical height of 2mm), which can be augmented with autogenous bone chips to improve soft tissue attachment. 9. The site intended for implant placement should have residual facial and palatal/lingual plates to be at least 1.0mm thick after implant placement. 10. The site intended for implant placement should have vertical bone volume to extend at least 2.0mm apical to the implant after implant placement. Exclusion Criteria: 1. Subjects mentally incompetent or unable to understand and provide an Informed Consent 2. Smokers, alcoholics or drug abusers 3. Subjects with systemic conditions such as uncontrolled diabetes, endocrine disorders, heart disease, immune-compromised subjects or mental disorders 4. Use of concurrent medication which inhibits bone metabolism like bisphosphonates, corticosteroids or methotrexate 5. Bleeding disorders and/or anticoagulant therapy 6. Pregnancy 7. Known sensitivity or allergy to any of the implant materials 8. Subjects with bruxism or clenching habits 9. Uncontrolled periodontal or oral pathologies (e.g. mucosal disease, oral lesions) 10. Inadequate oral hygiene 11. History of radiation at the site intended for study implant placement 12. Subjects who have previously failed dental implants at the site intended for study implant placement 13. Subjects participating in another clinical study 14. Subjects who need other surgeries in a site adjacent to the study implant(s) 15. Subjects who need other surgeries in a site non-adjacent to the study implant(s) within 6 months of study implant placement |
Country | Name | City | State |
---|---|---|---|
Germany | Heinrich Heine Universitat Dusseldorf | Dusseldorf | Nordhein-Westfalen |
Germany | Universitatsmedizin Mainz | Mainz | Rheinland-Pfalz |
Germany | Universitat Regensburg | Regensburg | Bayern |
Lead Sponsor | Collaborator |
---|---|
ZimVie |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implant Stability | Measure of Implant Stability Quotient immediately post implantation | 3-18 weeks | |
Secondary | Marginal bone level change | Measurement of bone level surrounding implant | 2 years |
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