T3 Short Dental Implants for Toothless Jaw

(Magnolia Trial)

Recruiting in Dearborn Heights (>99 mi)

+3 other 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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the T3 Short Dental Implant System treatment?

Research shows that short dental implants, like the T3 Short Dental Implant System, are effective in areas with limited bone height, maintaining bone stability and having high success rates over time. Studies indicate that these implants can be a reliable option for patients with severe bone loss in the jaw, providing stable support for dental restorations. ^{1 2 3 4 5}

Is the T3 Short Dental Implant System safe for use in humans?

Research shows that short dental implants, including those similar to the T3 Short Dental Implant System, generally have a high success rate and are considered safe. Studies found that these implants maintain bone stability and have a success rate of about 95.8% over three years, with no significant issues like pain or infection reported. ^{3 5 6 7 8}

How is the T3 Short Dental Implant System treatment different from other treatments for toothless jaws?

The T3 Short Dental Implant System is unique because it uses short implants that can be placed in areas with limited bone volume, avoiding the need for complex bone augmentation surgeries. This approach reduces treatment time, cost, and recovery, making it suitable for patients who cannot undergo extensive surgical procedures. ^{3 9 10 11 12}

What is the purpose of this trial?

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

Research Team

Hai Bo Wen, PhD

Principal Investigator

ZimVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-Term Results of Intraforaminal Immediately Loaded Implants and Posterior Mandibular Regrowth Evaluation in Severely Atrophic Mandibles. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Influence of crown-implant ratio on implant success rate of ultra-short dental implants: results of a 8- to 10-year retrospective study. [2020]

3. Spain pubmed.ncbi.nlm.nih.gov

Survival of immediately versus delayed loaded short implants: A prospective case series study. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

Meta-analysis on the survival of short implants. [2019]

5. Spain pubmed.ncbi.nlm.nih.gov

Extra short 4mm implants used to rehabilitation of atrophic posterior mandible. A serial case reports. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Novel expandable short dental implants in situations with reduced vertical bone height-technical note and first results. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Are short implants (≤8.5 mm) reliable in the rehabilitation of completely edentulous patients: A systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Performance of short implants in partial restorations: 3-year follow-up of Osseotite implants. [2022]

9. Spain pubmed.ncbi.nlm.nih.gov

Predictability of short implants ( [2019]

10. England pubmed.ncbi.nlm.nih.gov

In selected sites, short, rough-surfaced dental implants are as successful as long dental implants: a critical summary of Pommer B, Frantal S, Willer J, Posch M, Watzek G, Tepper G. Impact of dental implant length on early failure rates: a meta-analysis of observational studies. J Clin Periodontol 2011;38(9):856-863. [2019]

11. Denmark pubmed.ncbi.nlm.nih.gov

Short implant in limited bone volume. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Performance of Immediately Loaded Short Implants Using Low-Speed Drilling Protocol and Plasma Rich in Growth Factors: A Controlled Retrospective Observational Study. [2023]