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Dental Implant
Eztetic Dental Implants for Toothless Jaw (RoseQuartz Trial)
N/A
Waitlist Available
Led By Burak Yilmaz, DDS
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial involves using Eztetic dental implants to replace missing teeth in the front part of the upper or lower jaw. It targets patients needing single tooth replacements with stable back teeth. The implant serves as a root, with a temporary crown shaping the gum and a permanent crown placed after healing.
Who is the study for?
Adults with a toothless jaw who need dental implants in the front part of their mouth. They must have good bone stability, enough jaw width, and healthy gums. Smokers or those with certain health issues like uncontrolled diabetes, heart disease, severe periodontal disease, or infections are not eligible.
What is being tested?
The Eztetic Dental Implant System is being tested for people needing teeth replaced in the front lower or upper jaw. The study observes immediate loading of temporary crowns after implant surgery and final restorations within 6 months.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, swelling, bruising, bleeding during and after surgery; there's also a risk of infection or implant failure which could require additional treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Implant survival
Secondary study objectives
Marginal bone changes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Eztetic dental implantExperimental Treatment1 Intervention
Eztetic 3.1mm diameter, lengths 8, 10, 11.5, 13, 16 mm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eztetic dental implant
2019
N/A
~90
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatment for a toothless jaw, particularly using dental implants with immediate loading, involves the process of osseointegration. This is where the implant integrates with the jawbone, creating a stable and durable foundation for the prosthesis.
Immediate loading with a provisional prosthesis allows for the restoration of function and aesthetics soon after the implant placement, which is essential for improving the patient's quality of life. This approach reduces the waiting time for final restorations and helps maintain the structure and health of the jawbone, preventing bone loss and ensuring better long-term outcomes.
Study of the Clinical Efficiency of an Interdisciplinary Approach to the Treatment of Orofacial Pain and Temporomandibular Joint Disorders in Patients with Complete or Partial Edentulism.
Study of the Clinical Efficiency of an Interdisciplinary Approach to the Treatment of Orofacial Pain and Temporomandibular Joint Disorders in Patients with Complete or Partial Edentulism.
Find a Location
Who is running the clinical trial?
Zimmer BiometLead Sponsor
377 Previous Clinical Trials
67,943 Total Patients Enrolled
ZimVieLead Sponsor
26 Previous Clinical Trials
2,320 Total Patients Enrolled
Burak Yilmaz, DDSPrincipal InvestigatorOhio State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It is preferred if you have thick gums, but not having this characteristic won't prevent you from participating in the study.The study will enroll patients with intact buccal tableYou agree to be evaluated for each study visit.You have had previous unsuccessful implants in the area where the study implant will be placed.You have certain medical conditions like uncontrolled diabetes, heart disease, weakened immune system, or mental disorders.Patients with thick gums will be preferred for this study, but having thin gums will not automatically exclude you.Your teeth need to have a certain width to be eligible. Your front teeth should be at least 5.1mm wide from side to side, and the width between the inner surfaces of your teeth should be at least 6mm.You smoke more than 10 cigarettes a day.You need a bone graft in the area where the implant will be placed.You have received radiation treatment to your head or jaw in the past.You have severe habits like grinding or clenching your teeth.You are currently taking medications like ibuprofen, osteoporosis drugs, or steroids.You have had serious gum disease in the past.You are physically able to tolerate conventional surgical and restorative procedures.You have a set of teeth that can be temporarily replaced without affecting your ability to bite and chew properly.You need other medical treatments or surgeries near the area where the study treatment will be given.You have an ongoing infection or severe inflammation where the implant would be placed.
Research Study Groups:
This trial has the following groups:- Group 1: Eztetic dental implant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Toothless Jaw Patient Testimony for trial: Trial Name: NCT03917927 — N/A