A Clinical Study of the Eztetic Dental Implant System (RoseQuartz)

A Prospective Multicenter Study of the Integration Success of the Eztetic Dental Implant System in Immediate Loading Cases

This will be a prospective, observational multicenter study. All implants will be placed in the anterior maxilla or mandible and immediately loaded with a provisional prosthesis out of occlusion. Final restorations insertion will take place no later than 6 months following implant placement surgery. All implants will be restored with a single crown or splinted to a pre-existing implant if in the pre-molar region (no 2 adjacent edentulous sites).

Study Overview

• Status: Completed
• Conditions: Edentulous Jaw
• Intervention / Treatment: Device: Eztetic dental implant

Detailed Description

This will be a prospective, observational study in which patients in need of dental implants in the anterior regions of the maxilla or mandible will be treated with the Eztetic dental implant(s). Qualified patients will be those with one or more edentulous area in the anterior maxilla or mandible needing a single (restored as a single crown; if in the pre-molar region, it is recommended implant be splinted to another tooth or implant; no 2 adjacent edentulous sites). Qualified patients should have presence of posterior teeth or a stable posterior occlusion. All implants will be placed in a single-stage manner. A provisional abutment will be placed and a temporary crown will be placed (cemented or screw-retained) out of occlusion at implant placement surgery visit. Impressions for permanent prosthesis fabrication will take place at 6 weeks and prosthesis placement will take place at 2 months. Final prosthesis insertion will take place no later than 6 months following implant placement surgery. Resonance frequency assessment procedures will be done at implant placement surgery and at prosthesis insertion. Implant survival will be the primary study endpoint. Crestal bone regression will be the secondary study endpoint. Enrollment will continue until 20 patients have completed final prosthetic treatment at study center.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • San Jose Hospital
• Germany
  • Mainz, Germany, 55128
    • Dr. Tasso-Eyke von Haussen
• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Virginia
    • Richmond, Virginia, United States, 23298-0566
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eztetic dental implant; Eztetic 3.1mm diameter, lengths 8, 10, 11.5, 13, 16 mm	Device: Eztetic dental implant; narrow diameter dental implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival	survival (no declaration of failure) of dental implant	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal bone changes	Change in bone levels around dental implant	2 years

Collaborators and Investigators

• Sponsor: ZimVie
• Investigators: Principal Investigator: Burak Yilmaz, DDS, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: April 13, 2019
• First Submitted That Met QC Criteria: April 13, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: 1601 (University Hospital Bern)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No