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Implant
PrimeTaper EV Implant for Dental Implants
N/A
Waitlist Available
Led By Christopher Barwacz, DDS
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A stable occlusion (i.e., bite), i.e. an opposing natural dentition, a crown, an implant-supported fixed or removable prosthesis, a partial removable prosthesis or a full denture
Adult aged 18-75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up permanent restoration (baseline), and 1, 2, 3, 4, and 5 years
Awards & highlights
Study Summary
This trial is designed to study the success of a new type of dental implant after one year.
Who is the study for?
Adults aged 18-75 needing a dental implant, with stable bite and adjacent teeth or crowns. Must be able to pay for associated costs, attend all study visits over 5.5 years, and understand English without a translator. Excluded if pregnant/breastfeeding, allergic to materials used in implants, have certain diseases or conditions affecting healing/osseointegration, are smokers or have substance abuse issues.Check my eligibility
What is being tested?
The trial is testing the PrimeTaper EV Implant's success rate over five years after permanent restoration placement. Participants will undergo implant surgery followed by several check-ups and impressions for the final crown within six months post-surgery.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of dental implants can include pain at the implant site, swelling of gums and face, bruising of skin and gums, minor bleeding, and possible infection at the implant site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My teeth or dental replacements fit together properly when I bite down.
Select...
I am between 18 and 75 years old.
Select...
I need a dental implant in the upper or lower front teeth area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ permanent restoration (baseline), and 1, 2, 3, 4, and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~permanent restoration (baseline), and 1, 2, 3, 4, and 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Implants that Survived 1 year after Permanent Restoration
Secondary outcome measures
Condition of the periimplant mucosa - bleeding on probing (BoP)
Condition of the periimplant mucosa - plaque
Condition of the periimplant mucosa - probing pocket depth (PPD)
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PrimeTaper EV ImplantExperimental Treatment1 Intervention
All subjects will receive 1 PrimeTaper EV implant, UDI 0739253224012WR
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
446 Previous Clinical Trials
879,477 Total Patients Enrolled
Christopher Barwacz, DDSPrincipal InvestigatorUniversity of Iowa
1 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a dental implant in my upper or lower jaw but only one.My bite is stable, whether with my natural teeth or with dental work.I have a tooth or implant next to the gap where my implant will go, except if it's for a first molar.I do not have untreated dental issues like cavities or gum disease.I am not pregnant or breastfeeding.I am not on medications that could affect healing after surgery.My teeth or dental replacements fit together properly when I bite down.I have a condition that could affect healing after surgery.I am between 18 and 75 years old.I do not have any severe health issues that would prevent me from joining the study.I have a tooth or implant next to the gap where my implant will go, except if it's for a first molar.I need a dental implant in the upper or lower front teeth area.I need bone regeneration in the area planned for an implant.I can afford the costs for dental procedures including the crown, mouthwash, extraction, and bone grafting if needed.I don't have a history of head/neck radiation, recent chemotherapy, substance abuse, psychiatric illness, or current tobacco use.The investigator expects that the implant will remain stable at the beginning of the study.
Research Study Groups:
This trial has the following groups:- Group 1: PrimeTaper EV 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.
Implants Patient Testimony for trial: Trial Name: NCT05387421 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must a person fulfill to qualify for participation in this clinical trial?
"This clinical trial will accept 25 participants aged 18-75 with dental implants that comply to certain standards. The patients need to be able to comprehend English, have the financial means for a roughly $1300 crown plus other expenses and attend 11 visits over 5.5 years. Adjacent teeth must either contain natural or artificial crowns or an implant supported crown should sit mesially and distally around the planned implant (first molars are exempt)."
Answered by AI
Is enrollment open for the current trial?
"According to clinicaltrials.gov, this experiment is no longer accepting new participants as of May 18th 2022; its initial post date was July 1st 2022. Luckily, there are 5 other trials presently open for recruitment."
Answered by AI
Is the eligibility for this research study restricted to adults?
"This research requires individuals between 18 and 75 years old to take part. For those below the age of majority or elderly, there are two other studies they can join."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
Georgia
Texas
Other
What site did they apply to?
University of Iowa
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
0
What questions have other patients asked about this trial?
Yes. How long is this trial and when exactly would it start (if chosen)?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I really need implants. I need dehtalmimplants and cannot afford them currently.
PatientReceived no prior treatments
To help reconstruct my mouth for function and appearance. I am in dire need of dental implants. I am missing 4 teeth on top and 3 on bottom. I'm disabled and my only health.
PatientReceived no prior treatments
I have been putting off removing some teeth that need to be removed while I was waiting to have enough money to get implants.
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Email
Most responsive sites:
- University of Iowa: < 24 hours
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