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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.

Must not have

Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.

Patients with a history of generalized severe chronic periodontal disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am already approved for a dental implant in the back part of my upper or lower jaw.

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My jawbone near the cheek is healthy as confirmed by a special X-ray or during surgery.

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

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I am physically fit for surgery and recovery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a history of severe gum disease.

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

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I do not have uncontrolled diabetes, heart disease, or severe mental disorders.

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I have had radiation therapy to my head or jaw.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Crestal Bone regression

Secondary study objectives

Implant integration and survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met