A Clinical Study of the T3 Short Dental Implant System

NCT04237545 | Completed FDA Device

• 1 other identifier: 1801
• Study Type: interventional
• Target: 106
• Locations: 3 countries
• Sites: 4

Brief Summary

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

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

• Crestal Bone regression

  Assess and compare peri-implant crestal bone level changes between test and control device from baseline to 4 years

  4 years

Secondary Outcomes (1)

• Implant integration and survival

  4 years

Study Arms (2)

T3 short implant

EXPERIMENTAL

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.

Device: T3 short and restoration (prosthesis)

T3 standard length

ACTIVE COMPARATOR

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.

Device: T3 standard length and restoration (prosthesis)

Interventions

T3 short and restoration (prosthesis) DEVICE

A qualified patient will be treated with a T3 short implant according to randomization assignment during implant placement surgery visit. The implant will then be restored with a prosthesis and followed up for yearly visits for a total of 4 years.

Also known as: T3 short, T3

T3 short implant

T3 standard length and restoration (prosthesis) DEVICE

A qualified patient will be treated with a T3 standard length implant according to randomization assignment during implant placement surgery visit. The implant will then be restored with a prosthesis and followed up for yearly visits for a total of 4 years.

Also known as: T3

T3 standard length

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex and at least 18 years of age
• 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.
• Prior extracted sites (at least 4 months after extraction) preferred; immediate extractions allowed
• Splinting to a natural tooth is allowed for the short length (test) implants
• Intact buccal table as verified by CBCT or during surgery. If absent, patient should be excluded from enrollment in the study.
• Presence of opposing dentition (antagonist) that will allow for functional occlusion.
• The site intended for implant placement should have a minimum amount of keratinized gingiva of 2mm and a sufficient vertical bone height (8 - 10 mm in the maxilla; 10mm in the mandible); a short implant (as determined by randomization) will be placed without the need for augmentation except for minor dehiscence, which can be augmented with autogenous bone chips to improve soft tissue attachment. If site was randomized to long length implant (control) (with a minimum of 8mm vertical bone height in the maxilla or less than 10 mm in the mandible) it will have simultaneous augmentation procedure (sinus elevation in the maxilla; vertical ridge augmentation in the mandible).
• The site intended for implant placement should have approximately 1.5mm buccal-lingual distance on each side in order to allow for wide platform implant (5 and 6mm diameter).
• Patients must be physically able to tolerate conventional surgical and restorative procedures.
• Patients who provide a signed informed consent
• Patients who agree to be evaluated for each study visit.

You may not qualify if:

• Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders.
• Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.
• Patients with active infection or severe inflammation in the areas intended for treatment.
• Patients with a \> 10 cigarette per day smoking habit.
• Patients with a history of therapeutic radiation to the head or jaw.
• Patients receiving other dental treatment(s) during the study that could have a negative impact on the healing phase of the study treatment sites.
• Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
• Patients with evidence of severe parafunctional habits such as bruxing or clenching.
• Patients who have previously failed dental implants at the site intended for study implant placement
• Patients with HIV or Hepatitis infection
• Patients with a history of generalized severe chronic periodontal disease

Sponsors & Collaborators

• ZimVie: lead

Study Sites (4)

Dr. Xiaozhe Han

Boston, Massachusetts, 02111, United States

Location

Dr. Suheil Boutros

Dearborn Heights, Michigan, 48127, United States

Location

Dr. Stefano Sivolella

Padova, 35127, Italy

Location

Dr. Jordi Gargallo

Tarragona, Catalonia, 43002, Spain

Location

MeSH Terms

Conditions

Jaw, Edentulous

Interventions

Prostheses and Implants

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Hai Bo Wen, PhD

  ZimVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The randomization will be done using assignment from a computerized algorithm program. This will be done using a fixed block randomization scheme to ensure 1:1 ratio between test and control groups. Sealed envelopes containing randomization cards (code) will be used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The patient will be randomized to receive either the T3 short (test device) or the T3 standard length, ≥10mm, (control device) implant.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 23, 2020
• Study Start: October 1, 2019
• Primary Completion: January 1, 2026
• Study Completion: March 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); ES (1); IT (1)