Edentulous JawMagnoliaNCT04237545
A Clinical Study of the T3 Short Dental Implant System
A study testing T3 short and restoration (prosthesis) and T3 standard length and restoration (prosthesis) in people with Edentulous Jaw, run by ZimVie at 4 sites in 3 countries.
Trial summary
This clinical study will evaluate the safety and performance of the T3 short dental implant when placed in the posterior maxilla and mandible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- T3 short and restoration (prosthesis) and T3 standard length and restoration (prosthesis)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Oct 2019to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Dr. Xiaozhe Han
Boston, Massachusetts, 02111
Dr. Suheil Boutros
Dearborn Heights, Michigan, 48127
About this study
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
This clinical study will evaluate the safety and performance of the T3 short dental implant when placed in the posterior maxilla and mandible.
Read the 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.
- Conditions
- Edentulous Jaw
- Being tested
- T3 short and restoration (prosthesis), T3 standard length and restoration (prosthesis)
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3 short and restoration (prosthesis)Device
Also called T3 short, T3
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.
T3 standard length and restoration (prosthesis)Device
Also called T3
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: T3 standard length and restoration (prosthesis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal Bone regression
Assess and compare peri-implant crestal bone level changes between test and control device from baseline to 4 years
Measured: 4 years
Secondary outcomes (1)
Implant integration and survival
Assess and compare integration success (mobility and ISQ assessments) between test and control device from baseline to 4 years
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Oct 2019
- Primary completion1 Jan 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZimVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hai Bo Wen, PhD, Study director, ZimVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237545
- Sponsor's protocol ID
- 1801
- Acronym
- Magnolia
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2020
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04237545
- Acronym / sponsor ID
- Magnolia / 1801
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- ZimVieIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The patient will be randomized to receive either the T3 short (test device) or the T3 standard length, ≥10mm, (control device) implant.
| Arm | Type | Receives |
|---|---|---|
| T3 short implant | Experimental | Device: T3 short and restoration (prosthesis)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. |
| T3 standard length | Active comparator | Device: T3 standard length and restoration (prosthesis)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T3 short and restoration (prosthesis)Also: T3 short, T3A 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. | Device | T3 short implant |
| T3 standard length and restoration (prosthesis)Also: T3A 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. | Device | T3 standard length |
Primary outcome
Crestal Bone regression
Time frame: 4 years
Assess and compare peri-implant crestal bone level changes between test and control device from baseline to 4 years
1 secondary outcome
Implant integration and survival
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Edentulous Jaw
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Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
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Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hai Bo Wen, PhD study director
ZimVie
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T3 short and restoration (prosthesis) and T3 standard length and restoration (prosthesis) in people with Edentulous Jaw, run by ZimVie at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crestal Bone regression (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.