NCT03917927

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

4.4 years

First QC Date

April 13, 2019

Last Update Submit

January 24, 2024

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

  • Implant survival

    survival (no declaration of failure) of dental implant

    2 years

Secondary Outcomes (1)

  • Marginal bone changes

    2 years

Study Arms (1)

Eztetic dental implant

EXPERIMENTAL

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

Device: Eztetic dental implant

Interventions

Eztetic dental implantDEVICE

narrow diameter dental implant

Eztetic dental implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298-0566, United States

Location

San Jose Hospital

Santiago, Chile

Location

Dr. Tasso-Eyke von Haussen

Mainz, 55128, Germany

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Burak Yilmaz, DDS

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2019

First Posted

April 17, 2019

Study Start

January 8, 2019

Primary Completion

May 30, 2023

Study Completion

January 22, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)US(2)DE(1)