ClinicalTrials.gg
CompletedNCT02161874OAKUpdated Aug 18, 2026Results posted

Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System

An interventional study of T3 with DCD tapered Prevail implant and Nanotite Certain tapered implant in Partial Edentulism and Tooth Disease, sponsored by ZimVie. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by ZimVie · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Apr 2013, registered Jun 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Partial Edentulism
  • Tooth Disease

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Keywords

  • edentulism
  • dental implants
  • clinical study
  • endosseous
  • randomized
  • crestal bone level
  • T3
  • Nanotite Certain
  • Nanotite Certain Prevail
  • Tapered
03

In context

Tooth Diseases

79 studies on the registry are indexed under Tooth Diseases; 11 are open to participants now.

This study's enrollment of 40 is below the median of 49 across 63 interventional studies indexed under Tooth Diseases.

Browse Tooth Diseases studies →

Lead sponsor

ZimVie is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    T3 with DCD tapered Prevail implant

    T3 with DCD tapered prevail implant

    Device: T3 with DCD tapered Prevail implant

  • Active comparator
    Nanotite certain tapered implant

    Nanotite Certain tapered implant

    Device: Nanotite Certain tapered implant

Interventions

  • DeviceT3 with DCD tapered Prevail implant

    T3 with DCD implant with Certain (internal) connection and platform-switch design

    Also known as: T3 with Nanotite, T3 with platform switch

  • DeviceNanotite Certain tapered implant

    Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design

    Also known as: Nanotite tapered certain, Non-platform switched

06

What researchers measure

Primary outcomes

  1. Cumulative Success Rate

    Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.

    Time frame: 1 year

Secondary outcomes

  1. Crestal Bone Changes

    Crestal bone regression (amount of bone loss) between the two treatment groups will be compared

    Time frame: 2 years

07

Results

Posted May 22, 2026

Participant flow

Participant flow — Overall Study
MilestoneT3 With DCD Tapered Prevail ImplantNanotite Certain Tapered Implant
Started328
Completed273
Not completed55

Outcome measures

PrimaryCumulative Success Rate

Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.

Time frame:
1 year
Reported as:
Number · implants
Cumulative Success Rate
implantsT3 With DCD Tapered Prevail ImplantNanotite Certain Tapered Implant
Cumulative Success Rate617
SecondaryCrestal Bone Changes

Crestal bone regression (amount of bone loss) between the two treatment groups will be compared

Time frame:
2 years
Reported as:
Mean · millimeters
Crestal Bone Changes
millimetersT3 With DCD Tapered Prevail ImplantNanotite Certain Tapered Implant
Crestal Bone Changes1.8 ± 0.93.3 ± 1.3

Adverse events

Collected over from enrollment until the end of 5 year follow up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
T3 With DCD Tapered Prevail Implant0/32 (0%)0/32 (0%)6/32 (18.8%)
Nanotite Certain Tapered Implant0/8 (0%)0/8 (0%)4/8 (50%)
Most frequent other events
Most frequent other events
EventT3 With DCD Tapered Prevail ImplantNanotite Certain Tapered Implant
implant failureSurgical and medical procedures6/324/8

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)T3 With DCD Tapered ImplantNanotite Certain Tapered ImplantTotal
<=18 years000
Between 18 and 65 years22527
>=65 years10313
Sex: Female, Male
Sex: Female, Male(Participants)T3 With DCD Tapered ImplantNanotite Certain Tapered ImplantTotal
Female17522
Male15318
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)T3 With DCD Tapered ImplantNanotite Certain Tapered ImplantTotal
Count of participants——0
08

Study locations

4 sites
  • Dr. Tommie VanDeVelde
    Antwerp, Belgium
  • Dr. Dominique Caspar
    Les Bains, France
  • Dr. Felix Hanssler
    Göppingen, Germany
  • Dr. Nicholas Lewis
    London, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02161874
Lead sponsor
ZimVie
Responsible party
Sponsor
First posted
Jun 12, 2014
Start date
Apr 2013
Primary completion
Jan 2019
Completion
Jul 2020
Results posted
May 22, 2026
Last update
Aug 18, 2026

Study contacts

Nicholas Lewis, DMD
principal investigator · Eastman Dental Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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