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Dental Implant
T3 Short Dental Implants for Toothless Jaw (Magnolia Trial)
N/A
Waitlist Available
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients for whom a decision has already been made to use a dental implant for the restoration of existing partial edentulism in the posterior mandible or maxilla.
Intact buccal table as verified by CBCT or during surgery. If absent, patient should be excluded from enrollment in the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Magnolia Trial Summary
This trial will test how safe and effective the T3 short dental implant is when used in the back of the upper and lower jaw.
Who is the study for?
Adults with missing teeth in the back of their mouth who can undergo standard dental procedures. They must have enough bone height and gum tissue for implants, not smoke heavily, and not be on certain medications like anti-inflammatories or steroids. Pregnant individuals or those planning pregnancy soon cannot participate.Check my eligibility
What is being tested?
The study is testing two types of T3 dental implants: a short version and a standard length one. Both will be fitted with prostheses (artificial teeth). The goal is to see how safe and effective the short implant is when placed in the jaw without needing major bone grafting.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, swelling, bruising, bleeding, infection risk increase around the implant area, possible damage to surrounding teeth or blood vessels during surgery.
Magnolia Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am already approved for a dental implant in the back part of my upper or lower jaw.
Select...
My jawbone near the cheek is healthy as confirmed by a special X-ray or during surgery.
Select...
I have teeth that align and allow me to chew properly.
Select...
I am physically fit for surgery and recovery.
Magnolia Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Crestal Bone regression
Secondary outcome measures
Implant integration and survival
Magnolia Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: T3 short implantExperimental Treatment1 Intervention
The short implants are available in lengths of 5mm and 6mm and in diameters of 5mm and 6mm. For study both configurations, T3 short without nano-scale Discrete Crystalline Deposition (non DCD- surface treatment) and T3 short with nano-scale Discrete Crystalline Deposition (with DCD- surface treatment), will be used.
Group II: T3 standard lengthActive Control1 Intervention
The T3 external hex implants available for this study will consist of lengths of 10mm, 11.5mm, 13mm, 15mm, 18mm and diameters of 4mm, 5mm, and 6mm. They have integrated platform switching (medialized implant/abutment junction). For study both configurations, T3 without nano-scale Discrete Crystalline Deposition (non DCD- surface treatment) and T3 with nano-scale Discrete Crystalline Deposition (with DCD- surface treatment), will be used.
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Who is running the clinical trial?
Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,275 Total Patients Enrolled
ZimVieLead Sponsor
24 Previous Clinical Trials
2,139 Total Patients Enrolled
Hai Bo Wen, PhDStudy DirectorZimVie
1 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am already approved for a dental implant in the back part of my upper or lower jaw.My jawbone near the cheek is healthy as confirmed by a special X-ray or during surgery.I am currently taking anti-inflammatory drugs, bisphosphonates, or steroids.I have teeth that align and allow me to chew properly.I am 18 years old or older.I have a history of severe gum disease.My gum and bone are suitable for a dental implant as per the study's requirements.I had a tooth extraction at least 4 months ago, or I need one now.My dental implant is temporarily attached to a natural tooth.The area for my implant has enough space for a wide implant.I do not have an active infection or severe inflammation in the treatment area.I am physically fit for surgery and recovery.I do not have uncontrolled diabetes, heart disease, or severe mental disorders.I am not undergoing any dental treatments that could affect my study treatment's healing.I have had radiation therapy to my head or jaw.
Research Study Groups:
This trial has the following groups:- Group 1: T3 standard length
- Group 2: T3 short 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: NCT04237545 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals currently able to partake in this clinical investigation?
"According to the clinicaltrials.gov, this trial is not presently open for recruitment, having been last updated on March 24th 2022 after being initially posted October 1st 2019. However, 22 other trials are currently recruiting patients at this time."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Massachusetts
Georgia
Other
How old are they?
18 - 65
What site did they apply to?
Dr. Stefano Sivolella
Other
Dr. Suheil Boutros
Dr. Xiaozhe Han
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
I need implants and cant afford them. I want implants, since I can't afford dentures.
PatientReceived 2+ prior treatments
improve my quality oflife and to help the study. I’m hoping this trial might help me fix my teeth.
PatientReceived no prior treatments
I need a full mouth of dental implant restoration.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
When will the trial begin ? How long will screening process take? How long would I have to stay in your state?
PatientReceived no prior treatments
Will you be placing any implants in the front of the jaw? Both mandible and maxillary?
PatientReceived no prior treatments
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