Partial EdentulismOAKNCT02161874
Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System
A study testing T3 with DCD tapered Prevail implant and Nanotite Certain tapered implant in people with Partial Edentulism and Tooth Disease, run by ZimVie at 4 sites in 4 countries.
Trial summary
This study evaluates the T3 implant system for the preservation of alveolar crestal bone and the establishment of initial integration. The new surface-treated features of the implant may contribute to improved soft and hard tissue healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Edentulism, Tooth Disease
- What is being tested?
- T3 with DCD tapered Prevail implant and Nanotite Certain tapered implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Apr 2013to Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 any race greater than 18 years of age
- Patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla.
- Patients must be physically able to tolerate conventional surgical and restorative procedures.
- Patients must agree to be evaluated for each study visit, especially the yearly follow-up visits
Who cannot join
- Patients with active infection or severe inflammation in the areas intended for implant placement.
- Patients with a > 10 cigarette per day smoking habit.
- Patients with uncontrolled diabetes mellitus.
- Patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: Osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or Paget's disease of bone.
- Patients with a history of therapeutic radiation to the head
- Patients in need of bone grafting at the site of the intended study implant for augmentation purposes.
- Patients who are known to be pregnant at the screening visit.
- Patients with evidence of severe para-functional habits such as bruxing or clenching.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Prospective, Randomized-controlled Evaluation of Biomet 3i's T3 Implant System for Integration Success and the Preservation of Crestal Bone
This study evaluates the T3 implant system for the preservation of alveolar crestal bone and the establishment of initial integration. The new surface-treated features of the implant may contribute to improved soft and hard tissue healing. The success rate of the T3 implant will be no different than that of the control implant, which possess similar geometry but different surface treatments.
Read the detailed description
This prospective, randomized-controlled study will enroll qualified patients with partial edentulism who will be treated with at least two dental implants. Implant sites will be randomly assigned to receive either a test (T3 implant) or control (Nanotite Certain Tapered implant) with an 80:20 (test:control) randomization ratio.
All implants will be allowed to integrate without occlusal forces and final restorations will be cemented thereafter.
Cumulative success rate and crestal bone regression of both treatment groups will be the primary and secondary study endpoints, respectively.
- Conditions
- Partial Edentulism, Tooth Disease
- Being tested
- T3 with DCD tapered Prevail implant, Nanotite Certain tapered implant
- Keywords
- edentulism, dental implants, clinical study, endosseous, randomized, crestal bone level, T3, Nanotite Certain, Nanotite Certain Prevail, Tapered
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3 with DCD tapered Prevail implantDevice
Also called T3 with Nanotite, T3 with platform switch
T3 with DCD implant with Certain (internal) connection and platform-switch design
Nanotite Certain tapered implantDevice
Also called Nanotite tapered certain, Non-platform switched
Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design
| Study group | Role | What they receive |
|---|---|---|
| T3 with DCD tapered Prevail implant | Experimental | T3 with DCD tapered prevail implant Receives: Device: T3 with DCD tapered Prevail implant |
| Nanotite certain tapered implant | Active comparator | Nanotite Certain tapered implant Receives: Device: Nanotite Certain tapered implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Success Rate
Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.
Measured: 1 year
Secondary outcomes (1)
Crestal Bone Changes
Crestal bone regression (amount of bone loss) between the two treatment groups will be compared
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startApr 2013
- Primary completionJan 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Partial EdentulismStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZimVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Lewis, DMD, Principal investigator, Eastman Dental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161874
- Sponsor's protocol ID
- 3023
- Acronym
- OAK
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2014
- Last updated
- 18 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized-controlled Evaluation of Biomet 3i's T3 Implant System for Integration Success and the Preservation of Crestal Bone
- ClinicalTrials.gov ID
- NCT02161874
- Acronym / sponsor ID
- OAK / 3023
- Conditions
- Partial Edentulism, Tooth Disease
- Keywords
- edentulism, dental implants, clinical study, endosseous, randomized, crestal bone level, T3, Nanotite Certain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ZimVieIndustry (pharma, biotech, devices)
- Study start
- Apr 2013 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the T3 implant system for the preservation of alveolar crestal bone and the establishment of initial integration. The new surface-treated features of the implant may contribute to improved soft and hard tissue healing. The success rate of the T3 implant will be no different than that of the control implant, which possess similar geometry but different surface treatments.
Detailed description
This prospective, randomized-controlled study will enroll qualified patients with partial edentulism who will be treated with at least two dental implants. Implant sites will be randomly assigned to receive either a test (T3 implant) or control (Nanotite Certain Tapered implant) with an 80:20 (test:control) randomization ratio.
All implants will be allowed to integrate without occlusal forces and final restorations will be cemented thereafter.
Cumulative success rate and crestal bone regression of both treatment groups will be the primary and secondary study endpoints, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T3 with DCD tapered Prevail implant | Experimental | Device: T3 with DCD tapered Prevail implantT3 with DCD tapered prevail implant |
| Nanotite certain tapered implant | Active comparator | Device: Nanotite Certain tapered implantNanotite Certain tapered implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of either sex and any race greater than 18 years of age
- Patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla.
- Patients must be physically able to tolerate conventional surgical and restorative procedures.
- Patients must agree to be evaluated for each study visit, especially the yearly follow-up visits
Key exclusion criteria (8 listed)
- Patients with active infection or severe inflammation in the areas intended for implant placement.
- Patients with a > 10 cigarette per day smoking habit.
- Patients with uncontrolled diabetes mellitus.
- Patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: Osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or Paget's disease of bone.
- Patients with a history of therapeutic radiation to the head
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 with DCD tapered Prevail implantAlso: T3 with Nanotite, T3 with platform switchT3 with DCD implant with Certain (internal) connection and platform-switch design | Device | T3 with DCD tapered Prevail implant |
| Nanotite Certain tapered implantAlso: Nanotite tapered certain, Non-platform switchedNanotite (DCD) implant with Certain (internal) connection and non- platform-switch design | Device | Nanotite certain tapered implant |
Primary outcome
Cumulative Success Rate
Time frame: 1 year
Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.
1 secondary outcome
Crestal Bone Changes
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Partial Edentulism
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Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
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Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
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Survival of Implant-Supported All-Ceramic Prostheses
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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.
Nicholas Lewis, DMD principal investigator
Eastman Dental Hospital
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T3 with DCD tapered Prevail implant and Nanotite Certain tapered implant in people with Partial Edentulism and Tooth Disease, run by ZimVie at 4 sites in 4 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 4 inclusion and 8 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 18 Aug 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 Belgium, France, Germany, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cumulative Success Rate (time frame: 1 year). 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 18 Aug 2026.