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

Primary Purpose

Edentulous Jaw

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Eztetic dental implant

About this trial

This is an interventional treatment trial for Edentulous Jaw

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients of either sex and at least 18 years of age
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)
Immediate extraction or a prior extracted site
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.
Patients must be physically able to tolerate conventional surgical and restorative procedures.
Patients with a facial lingual width of at least 5.1mm and inner tooth width of at least 6mm.
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.
Presence of opposing dentition with a functional occlusion that permits the restoration with a non-occluding provisional prosthesis.
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)
Patients who agree to be evaluated for each study visit.
Minimum primary stability, insertion torque > 35Ncm (this will be a criteria that is met at the time of surgery)

Exclusion Criteria:

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

Sites / Locations

Ohio State University
Virginia Commonwealth University
San Jose Hospital
Dr. Tasso-Eyke von Haussen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eztetic dental implant

Arm Description

Eztetic 3.1mm diameter, lengths 8, 10, 11.5, 13, 16 mm

Outcomes

Primary Outcome Measures

Implant survival

survival (no declaration of failure) of dental implant

Secondary Outcome Measures

Marginal bone changes

Change in bone levels around dental implant

Full Information

NCT ID

NCT03917927

First Posted

April 13, 2019

Last Updated

July 11, 2023

Sponsor

ZimVie

1. Study Identification

Unique Protocol Identification Number

NCT03917927

Brief Title

A Clinical Study of the Eztetic Dental Implant System

Acronym

RoseQuartz

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 8, 2019 (Actual)

Primary Completion Date

May 30, 2023 (Actual)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ZimVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edentulous Jaw

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Eztetic dental implant

Arm Type

Experimental

Arm Description

Eztetic 3.1mm diameter, lengths 8, 10, 11.5, 13, 16 mm

Intervention Type

Device

Intervention Name(s)

Eztetic dental implant

Intervention Description

narrow diameter dental implant

Primary Outcome Measure Information:

Title

Implant survival

Description

survival (no declaration of failure) of dental implant

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Marginal bone changes

Description

Change in bone levels around dental implant

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients of either sex and at least 18 years of age 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) Immediate extraction or a prior extracted site 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. Patients must be physically able to tolerate conventional surgical and restorative procedures. Patients with a facial lingual width of at least 5.1mm and inner tooth width of at least 6mm. 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. Presence of opposing dentition with a functional occlusion that permits the restoration with a non-occluding provisional prosthesis. 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) Patients who agree to be evaluated for each study visit. Minimum primary stability, insertion torque > 35Ncm (this will be a criteria that is met at the time of surgery) Exclusion Criteria: Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders. Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments. Patients with active infection or severe inflammation in the areas intended for implant placement. Prisoners Patients with a > 10 cigarette per day smoking habit. Patients with a history of therapeutic radiation to the head or jaw. Patients in need of bone grafting at the site of the intended implantation site(s). Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment. Patients with evidence of severe parafunctional habits such as bruxing or clenching. Patients with HIV or Hepatitis infection Patients who have previously failed implants at the site intended for study implant placement Patients in need of other treatments or surgeries at a site adjacent to the intended implantation site Patients with a history of severe periodontal disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Burak Yilmaz, DDS

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298-0566

Country

United States

Facility Name

San Jose Hospital

City

Santiago

Country

Chile

Facility Name

Dr. Tasso-Eyke von Haussen

City

Mainz

ZIP/Postal Code

55128

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Clinical Study of the Eztetic Dental Implant System

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