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.

ZimVie3 sites in 1 country120 target enrollmentMarch 2013

ConditionsPartial Edentulism Tooth Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Partial Edentulism
Sponsor: ZimVie
Enrollment: 120
Locations: 3
Primary Endpoint: Implant Stability
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

July 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ZimVie

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Benefit from the implant and restoration
•Provide a voluntarily signed Informed Consent
•Must be 18 years or older
•Have one or more edentulous area(s) in the posterior maxilla or mandible designated for an implant supported restoration
•The implantation site must have a functional antagonist to obtain full occlusion.
•Implants adjacent to planned site of implantation should have been in function for at least 1 year.
•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.
•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.
•The site intended for implant placement should have residual facial and palatal/lingual plates to be at least 1.0mm thick after implant placement.
•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

•Subjects mentally incompetent or unable to understand and provide an Informed Consent
•Smokers, alcoholics or drug abusers
•Subjects with systemic conditions such as uncontrolled diabetes, endocrine disorders, heart disease, immune-compromised subjects or mental disorders
•Use of concurrent medication which inhibits bone metabolism like bisphosphonates, corticosteroids or methotrexate
•Bleeding disorders and/or anticoagulant therapy
•Known sensitivity or allergy to any of the implant materials
•Subjects with bruxism or clenching habits
•Uncontrolled periodontal or oral pathologies (e.g. mucosal disease, oral lesions)
•Inadequate oral hygiene
•History of radiation at the site intended for study implant placement