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The Eztetic Dental Implant System

December 2, 2019

Overview

This is an observational study in which patients in need of dental implants in the front regions of the maxilla or mandible (upper or lower jaw) will be treated with the Eztetic dental implant(s). The primary aim of this study is to assess the implant survival time, and the secondary aim is to assess the changes in the bone levels around the implant site. 

 

Study Information

An estimated 20 participants will be recruited for this study, all of whom will have either posterior teeth or a stable posterior occlusion. The study began on January 8th 2019 and is estimated to be completed by December 2022. 

 

Inclusion Criteria

 

  1. Patients of either sex and at least 18 years of age
  2. Patients for whom a decision has already been made to use a dental implant for the restoration of existing partial edentulism in the anterior (central and lateral incisors), canine or pre-molar regions in the mandible or maxilla. Placing implant in canine region should be in a healed site (not for immediate extraction)
  3. Immediate extraction or a prior extracted site
  4. Intact buccal table as verified by Cone Beam Computed Tomography (CBCT) or radiography during surgery. If absent, patient should be excluded from enrollment in the study.
  5. Patients must be physically able to tolerate conventional surgical and restorative procedures.
  6. Patients with a facial lingual width of at least 5.1mm and inner tooth width of at least 6mm.
  7. Patients having a thick gingival biotype (based on the lack of transparency of the periodontal probe through the gingival margin while probing the buccal sulcus) will be preferred but lack of this characteristic will not disqualify a patient from inclusion in this study.
  8. Presence of opposing dentition with a functional occlusion that permits the restoration with a non-occluding provisional prosthesis.
  9. Patients who provide a signed informed consent; a patient having implant placement surgery will continue participation in the study regardless of whether or not they receive restorative treatment according to protocol (protocol deviation)
  10. Patients who agree to be evaluated for each study visit.
  11. Minimum primary stability, insertion torque > 35Ncm (this will be a criteria that is met at the time of surgery)

 

Exclusion Criteria

 

  1. Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders.
  2. Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.
  3. Patients with active infection or severe inflammation in the areas intended for implant placement.
  4. Prisoners
  5. Patients with a > 10 cigarette per day smoking habit.
  6. Patients with a history of therapeutic radiation to the head or jaw.
  7. Patients in need of bone grafting at the site of the intended implantation site(s).
  8. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
  9. Patients with evidence of severe parafunctional habits such as bruxing or clenching.
  10. Patients with HIV or Hepatitis infection
  11. Patients who have previously failed implants at the site intended for study implant placement
  12. Patients in need of other treatments or surgeries at a site adjacent to the intended implantation site
  13. Patients with a history of severe periodontal disease

 

Location

This study is located at Ohio State University, Columbus, Ohio, United States, 43210. For more information, please contact Burak Yilmaz, DDS on 614-547-7900 or at yilmaz.16@osu.edu

 

Sponsors/Collaborators

This study is sponsored by Zimmer Biomet, with Burak Yilmaz, DDS as the Principal Investigator.

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