Edentulous JawRoseQuartzNCT03917927
A Clinical Study of the Eztetic Dental Implant System
A study testing Eztetic dental implant in people with Edentulous Jaw, run by ZimVie at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- Eztetic dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 8 Jan 2019to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Ohio State University
Columbus, Ohio, 43210
Virginia Commonwealth University
Richmond, Virginia, 23298-0566
About this study
Official title: 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).
Read the 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.
- Conditions
- Edentulous Jaw
- Being tested
- Eztetic dental implant
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eztetic dental implantDevice
narrow diameter dental implant
| Study group | Role | What they receive |
|---|---|---|
| Eztetic dental implant | Experimental | Eztetic 3.1mm diameter, lengths 8, 10, 11.5, 13, 16 mm Receives: Device: Eztetic dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Implants Surviving up to 2 Years
survival (no declaration of failure) of dental implant
Measured: 2 years
Secondary outcomes (1)
Marginal Crestal Bone Changes up to 2 Years
Average change in bone levels around dental implant at 2 years as compared to that of baseline (time of implant placement)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start8 Jan 2019
- Primary completion30 May 2023
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZimVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Burak Yilmaz, DDS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917927
- Sponsor's protocol ID
- 1601
- Acronym
- RoseQuartz
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2019
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study of the Integration Success of the Eztetic Dental Implant System in Immediate Loading Cases
- ClinicalTrials.gov ID
- NCT03917927
- Acronym / sponsor ID
- RoseQuartz / 1601
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- ZimVieIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Posted 12 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eztetic dental implant | Experimental | Device: Eztetic dental implantEztetic 3.1mm diameter, lengths 8, 10, 11.5, 13, 16 mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eztetic dental implantnarrow diameter dental implant | Device | Eztetic dental implant |
Primary outcome
Number of Implants Surviving up to 2 Years
Time frame: 2 years
survival (no declaration of failure) of dental implant
1 secondary outcome
Marginal Crestal Bone Changes up to 2 Years
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burak Yilmaz, DDS principal investigator
Ohio State University
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eztetic dental implant in people with Edentulous Jaw, run by ZimVie at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Chile, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Implants Surviving up to 2 Years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.