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A Clinical Study of the T3 Short Dental Implant System (Magnolia)

Primary Purpose

Edentulous Jaw

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

T3 short and restoration (prosthesis)

T3 standard length and restoration (prosthesis)

About this trial

This is an interventional treatment trial for Edentulous Jaw

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Dr. Xiaozhe Han
Dr. Suheil Boutros
Dr. Stefano Sivolella
Dr. Jordi Gargallo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

T3 short implant

T3 standard length

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Crestal Bone regression

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

Secondary Outcome Measures

Implant integration and survival

Assess and compare integration success (mobility and ISQ assessments) between test and control device from baseline to 4 years

Full Information

NCT ID

NCT04237545

First Posted

January 17, 2020

Last Updated

July 11, 2023

Sponsor

ZimVie

1. Study Identification

Unique Protocol Identification Number

NCT04237545

Brief Title

A Clinical Study of the T3 Short Dental Implant System

Acronym

Magnolia

Official Title

A Prospective, Randomized, Clinical Study of the Safety, Efficacy and Clinical Benefits of the T3® Short Dental Implant System Placed in the Posterior Regions

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ZimVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a prospective, randomized-controlled, multicenter study in which patients in need of dental implants in the posterior maxilla and mandible will be treated with either the T3 short implant (test device) or the T3 standard length implant (control device). Qualified patients will have one or more edentulous areas in the posterior region to be restored using a single crown. All implants will be placed using a single-stage surgical protocol. A provisional or definitive (final) prosthesis will be placed (cemented or screw-retained) within 8 weeks of implant placement. All prosthetic work must be completed no later than 6 months following implant placement surgery. Each site will be selected to place implants (both test and control) in either the DCD or the non-DCD configuration (a total of 30 implants per site). Among all study sites, a total of 120 implants (60 test, 60 control) will be enrolled in this study (any geographic region). The patient will be randomized to receive either the T3 short (test device) or the T3 standard length, ≥10mm, (control device) implant. Only patients meeting the inclusion / exclusion criteria and providing informed consent form will be enrolled into study. The duration of the study will be approximately 4 years from initiation to completion of data analysis and reporting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Edentulous Jaw

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Investigator

Masking Description

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.

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

T3 short implant

Arm Type

Experimental

Arm Description

Arm Title

T3 standard length

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

T3 short and restoration (prosthesis)

Other Intervention Name(s)

T3 short, T3

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

T3 standard length and restoration (prosthesis)

Other Intervention Name(s)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Crestal Bone regression

Description

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

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Implant integration and survival

Description

Assess and compare integration success (mobility and ISQ assessments) between test and control device from baseline to 4 years

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hai Bo Wen, PhD

Organizational Affiliation

ZimVie

Official's Role

Study Director

Facility Information:

Facility Name

Dr. Xiaozhe Han

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Dr. Suheil Boutros

City

Dearborn Heights

State/Province

Michigan

ZIP/Postal Code

48127

Country

United States

Facility Name

Dr. Stefano Sivolella

City

Padova

ZIP/Postal Code

35127

Country

Italy

Facility Name

Dr. Jordi Gargallo

City

Tarragona

State/Province

Catalonia

ZIP/Postal Code

43002

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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A Clinical Study of the T3 Short Dental Implant System

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