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Dental Implant
PrimeTaper EV Implant for Missing Teeth Restoration
N/A
Waitlist Available
Led By Andy Temmerman, Prof.
Research Sponsored by Dentsply Sirona Implants
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A stable occlusion, 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 at date of implant placement (anticipated average 1 month after inclusion).
Awards & highlights
Study Summary
This trial looks at how well the PrimeTaper EV implant works in single tooth restorations, specifically how long the implant lasts.
Who is the study for?
Adults aged 18-75 needing a single tooth implant in specific positions of the jaw, with stable occlusion and adjacent teeth or crowns. Excludes those allergic to titanium/stainless steel, with uncontrolled oral diseases, bruxism, immunosuppression, recent heavy treatments (chemo/radiation), substance abuse, severe systemic diseases or conditions affecting healing.Check my eligibility
What is being tested?
The trial is testing the PrimeTaper EV implant's success rate for single tooth restorations after one year. It aims to assess how well this particular dental implant survives and integrates into the jawbone over time.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 infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have stable teeth or dental work that allows me to chew properly.
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I am between 18 and 75 years old.
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I am between 18 and 75 years old.
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My dental setup is stable with either natural teeth or dental work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after implant placement (anticipated average 1 month after inclusion).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after implant placement (anticipated average 1 month after inclusion).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Implant survival, i.e. number of implants in place counted clinically, 1 year after permanent restoration.
Secondary outcome measures
Change of implant stability quotient value (ISQ) between implant placement and permanent restoration.
Change of marginal bone level up to 5 years post permanent restoration compared to permanent restoration.
Change of probing pocket depth (PPD) in mm between permanent restoration, and 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single tooth restorationsExperimental Treatment1 Intervention
A single, open-label group with patients in need of single tooth restorations will receive PrimeTaper EV implant system with diameters 3.6, 4.2, 4.8, 5.4 mm, and lengths 6.5, 8, 9, 11, 13, 15 and 17 mm.
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Who is running the clinical trial?
Dentsply Sirona ImplantsLead Sponsor
62 Previous Clinical Trials
4,517 Total Patients Enrolled
Dentsply Sirona Implants and ConsumablesLead Sponsor
65 Previous Clinical Trials
4,612 Total Patients Enrolled
Andy Temmerman, Prof.Principal InvestigatorKU Leuven
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active, severe infection.I have not had radiation therapy in my head or neck area.I have not had a stroke in the last 3 months.I have a bleeding disorder.I am not on medications that could affect healing after surgery.I have severe liver problems.I am not pregnant or breastfeeding.I do not have any health issues that could affect healing after surgery.I have a tooth or implant next to the gap where my implant will go, except if it's for a first molar.I have stable teeth or dental work that allows me to chew properly.The investigator believes that your implant is stable enough to begin the study.I need bone regeneration in the area planned for an implant.I have had chemotherapy within the last 5 years.I have not had a heart attack in the last 3 months.I have or might have another type of cancer.You are willing and able to sign and date the informed consent form.I am between 18 and 75 years old.I am between 18 and 75 years old.I do not have untreated dental issues like cavities or gum disease.My diabetes is not well-managed.My dental setup is stable with either natural teeth or dental work.
Research Study Groups:
This trial has the following groups:- Group 1: Single tooth restorations
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.
Partially Edentulous Jaw Patient Testimony for trial: Trial Name: NCT05315414 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment currently need volunteers?
"According to details published on clinicaltrials.gov, the research study is actively seeking participants and was initially made available for public view on May 3rd 2022 with a final update occurring at the end of September."
Answered by AI
Is eligibility for this medical experiment restricted to individuals aged sixty or younger?
"This study seeks participants aged 18 and older, yet below 75 years old."
Answered by AI
How many participants have been recruited for this clinical experiment?
"Affirmative. According to data available on clinicaltrials.gov, this trial was first posted on May 3rd 2022 and is actively recruiting patients as of September 28th 2022. The study seeks 137 participants at 1 medical centre."
Answered by AI
Could I potentially qualify to join this experiment?
"This medical trial is enrolling 137 individuals aged between 18 and 75 who have a partially edentulous jaw. To be eligible, patients must satisfy the following conditions: Adult aged 18-75 years., Willing to sign an informed consent form., Requiring implants in teeth 16-26 or 36-46 (one implant per person)., Deemed likely to present with initially stable implant situation by doctor., A steady occlusion of natural dentition, crowns, prosthesis or full dentures adjacent to planned implant mesially/distally. Exemption for first molar position if there is an empty space distal from it."
Answered by AI
Who else is applying?
What state do they live in?
Alabama
California
Nevada
Other
How old are they?
18 - 65
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?
1
0
Why did patients apply to this trial?
I have teeth that need to be replaced.and would live to try this out. I need implants, or at the very least partials for both upper and lower missing back molars, all except one which meeds to be extracted and bone grafts.
PatientReceived 1 prior treatment
I've been needing single tooth restorations for years now. My jaw has started repositioning, both top and bottem teeth are trying to find teeth that aren't there when chewing, have gain multiple scars on tongue and under lips from eating. Very painful! This is the trial I've waited on. Thank you!
PatientReceived 1 prior treatment
I currently have my molar and premolar extracted since August of 2022, and now my dentist says the molar and premolar on the left side of my mouth has to get extracted as well. The cost of getting so many implants is really expensive and it's almost impossible to be able to afford the cost of treatment within the US.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long do the screenings take? Is it possible to get more than one dental implant?
PatientReceived 1 prior treatment
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