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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2022
Source ZimVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized-controlled, multicenter study of Trabecular Metal (TM) and Tapered Screw-Vent (TSV) dental implants loaded early in maxillary and mandibular sites.


Description:

This is a randomized, controlled, multicenter study to assess and compare implant stability of Trabecular Metal (TM) dental implants and Tapered Screw-Vent (TSV) implants during the early stages of healing i.e. 21 +/- 2 days and 42+/- 2 days, as well as their short term clinical outcomes.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Trabecular metal dental implants (TM)
Patients receive TM dental implants in this arm. The early stability is measured and compared to the stability of the TSV implants. The implants are loaded and provisionalized early at 3 or 6 weeks if stability permits.
Tapered screw-vent implants (TSV)
Patients receive TSV dental implants in this arm. The early stability is measured and compared to the stability of the TM implants. The implants are loaded and provisionalized early at 3 or 6 weeks if stability permits.

Locations

Country Name City State
Germany Heinrich Heine Universitat Dusseldorf Dusseldorf Nordhein-Westfalen
Germany Universitatsmedizin Mainz Mainz Rheinland-Pfalz
Germany Universitat Regensburg Regensburg Bayern

Sponsors (1)

Lead Sponsor Collaborator
ZimVie

Country where clinical trial is conducted

Germany, 

Outcome

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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