ClinicalTrials.gg
CompletedNCT03917927RoseQuartzUpdated Aug 12, 2026Results posted

A Clinical Study of the Eztetic Dental Implant System

An interventional study of Eztetic dental implant in Edentulous Jaw, sponsored by ZimVie. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by ZimVie · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2019, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Edentulous Jaw

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03

In context

Jaw, Edentulous

122 studies on the registry are indexed under Jaw, Edentulous; 20 are open to participants now.

This study's enrollment of 82 is above the median of 24 across 99 interventional studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

ZimVie is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ; 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

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 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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Eztetic dental implant

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

    Device: Eztetic dental implant

Interventions

  • DeviceEztetic dental implant

    narrow diameter dental implant

06

What researchers measure

Primary outcomes

  1. Number of Implants Surviving up to 2 Years

    survival (no declaration of failure) of dental implant

    Time frame: 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)

    Time frame: 2 years

07

Results

Posted Aug 12, 2026

Participant flow

Participant flow — Overall Study
MilestoneEztetic Dental Implant
Started82
Completed55
Not completed27

Outcome measures

PrimaryNumber of Implants Surviving up to 2 Years

survival (no declaration of failure) of dental implant

Time frame:
2 years
Reported as:
Number · implants
Number of Implants Surviving up to 2 Years
implantsEztetic Dental Implant
Number of Implants Surviving up to 2 Years58
SecondaryMarginal 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)

Time frame:
2 years
Reported as:
Mean · millimeters
Marginal Crestal Bone Changes up to 2 Years
millimetersEztetic Dental Implant
Marginal Crestal Bone Changes up to 2 Years0.19 ± 0.4

Adverse events

Collected over from enrollment until the end of 2 year follow up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Eztetic Dental Implant0/82 (0%)0/82 (0%)4/82 (4.9%)
Most frequent other events
Most frequent other events
EventEztetic Dental Implant
implant failureSurgical and medical procedures4/82

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Eztetic Dental Implant
<=18 years0
Between 18 and 65 years75
>=65 years7
Sex: Female, Male
Sex: Female, Male(Participants)Eztetic Dental Implant
Female57
Male25
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Eztetic Dental Implant
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander3
Black or African American5
White74
More than one race0
Unknown or Not Reported0
08

Study locations

4 sites
  • Ohio State University
    Columbus, Ohio 43210, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23298-0566, United States
  • San Jose Hospital
    Santiago, Chile
  • Dr. Tasso-Eyke von Haussen
    Mainz, 55128, Germany
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2019 to primary completion in May 2023, 52 months.

Results were first posted in Aug 2026, 3 years 2 months after primary completion.

Of 66 interventional studies with no phase under Jaw, Edentulous, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's 52 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2019
First posted
Apr 17, 2019
StartActual
Jan 8, 2019
Primary completionActual
May 30, 2023
CompletionActual
Jul 1, 2026
Results first posted
Aug 12, 2026
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03917927
Lead sponsor
ZimVie
Responsible party
Sponsor
First posted
Apr 17, 2019
Start date
Jan 8, 2019
Primary completion
May 30, 2023
Completion
Jul 1, 2026
Results posted
Aug 12, 2026
Last update
Aug 12, 2026

Study contacts

Burak Yilmaz, DDS
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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