T3 Short Dental Implants for Toothless Jaw

(Magnolia Trial)

Not currently recruiting at 4 trial locations

Overseen By Hai Bo Wen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Must not be taking: NSAIDs, Bisphosphonates, Corticosteroids

Disqualifiers: Uncontrolled diabetes, Heart disease, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of the T3 short dental implant for individuals missing teeth in the back of their upper or lower jaws. Researchers will compare standard-length implants with experimental short implants to determine which performs better or if both are equally effective. Participants must have already decided to receive a dental implant and have missing teeth in the back area of their mouth. As an unphased trial, this study provides participants the opportunity to contribute to valuable research that could enhance dental implant options for future patients.

Will I have to stop taking my current medications?

The trial excludes patients who are currently using non-steroidal anti-inflammatory drugs, bisphosphonates, or corticosteroid treatments, so you may need to stop these medications to participate.

What prior data suggests that the T3 short dental implant system is safe for use in the posterior maxilla and mandible?

Research has shown that T3 dental implants, both regular and short versions, have been studied for safety and effectiveness. In past studies, the T3 implant proved to be safe, with most patients experiencing few serious side effects. Researchers have also tested the short implants, which are smaller than the regular ones.

These short implants are designed for specific areas of the jaw and come in various sizes. Some studies have examined different surface treatments to determine their impact on safety or performance. So far, evidence suggests that both the regular and short implants are safe to use.

While the current trial phase doesn't require a specific safety check, earlier studies have not shown any major safety issues, providing confidence in their use. It is always important to discuss any concerns with a dentist or healthcare provider when considering joining a trial or getting an implant. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the T3 Short Dental Implant System because it offers a promising alternative for those with toothless jaws who need implants in areas with limited bone height. Unlike traditional implants that require longer lengths and more bone, the T3 short implants come in shorter lengths of 5mm and 6mm, making them ideal for patients with less bone to work with. Additionally, these implants are available with a nano-scale Discrete Crystalline Deposition surface treatment, potentially enhancing their stability and integration with the jawbone. This could lead to better outcomes and shorter recovery times compared to standard length implants.

What evidence suggests that the T3 short dental implant is effective for toothless jaws?

Research has shown that short dental implants, like the T3 Short Dental Implant System, perform well in areas with limited bone. This trial will compare T3 short implants to T3 standard-length implants. Studies have found that these shorter implants can be as successful as regular-length implants, even in challenging areas of the mouth. Specifically, previous patients experienced similar success with short implants compared to longer ones, making them a good option for individuals with less bone. The T3 implants, whether treated with a special surface or not, have demonstrated stability, indicating they are likely to remain in place and function effectively over time. ^{2 3 4 6 7}

Who Is on the Research Team?

Hai Bo Wen, PhD

Principal Investigator

ZimVie

Are You a Good Fit for This Trial?

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.

Inclusion 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 have teeth that align and allow me to chew properly.

Exclusion Criteria

I am currently taking anti-inflammatory drugs, bisphosphonates, or steroids.

I have a history of severe gum disease.

I do not have an active infection or severe inflammation in the treatment area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the T3 short implant or the T3 standard length implant in the posterior maxilla and mandible

8 weeks

Implant placement and prosthesis placement visits

Prosthetic Work Completion

All prosthetic work must be completed following implant placement surgery

6 months

Follow-up

Participants are monitored for implant integration, survival, and crestal bone regression

4 years

What Are the Treatments Tested in This Trial?

Interventions

• T3 Short Dental Implant System

Trial Overview

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.

How Is the Trial Designed?

Group I: T3 short implant Experimental Treatment 1 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 length Active Control 1 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.

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

ZimVie

Lead Sponsor

Trials

27

Recruited

2,400+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05062863

An Observational Clinical Study of the T3 Dental Implant ...

This study aims to enroll a total of 140 patients (140 implants) who are in need of treatment with dental implants in one or more edentulous areas of the ...

2.

clinicaltrial.be

clinicaltrial.be/en/details/4164?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

A Clinical Study of the T3 Short Dental Implant System -...

This is a prospective, randomized-controlled, multicenter study in which patients in need of dental implants in the posterior maxilla and ...

3.

withpower.com

withpower.com/trial/phase-jaw-edentulous-9-2019-f4d3a

T3 Short Dental Implants for Toothless Jaw (Magnolia Trial)

Research shows that short dental implants, like the T3 Short Dental Implant System, are effective in areas with limited bone height, maintaining bone stability ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05498662

An Observational Study of the T3 Pro Dental Implant System

A prospective, observational, multicenter study where 60 patients needing implants in the maxilla or mandible will be enrolled.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8199359/

Short Dental Implants (≤8.5 mm) versus Standard ...

Shorter implants (7 and 8.5 mm in length) can be just as useful as standard-length implants in atrophic alveolar ridges, demonstrating similar rates of ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05062863

An Observational Clinical Study of the T3 Dental Implant ...

Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

7.

clinconnect.io

clinconnect.io/trials/NCT04237545

A Clinical Study of the T3 Short Dental Implant System

This clinical study will evaluate the safety and performance of the T3 short dental implant when placed in the posterior maxilla and mandible.