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CompletedNCT00726063CollegeBowlUpdated Jul 28, 2026Results posted

A Prospective Study Evaluating the Performance of Nanotite Osseotite Implants When Placed by Graduate Student Programs

An interventional study of Nanotite dental implant and Osseotite dental implant in Tooth Disease and Partial Edentulism, sponsored by ZimVie. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by ZimVie · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2008, registered Jul 2008).
Phase
Not applicable
Study type
Interventional
Enrollment
241
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate the contributions of the Nanotite implant design when used by graduate students in their first year of placing implants.

Read the detailed description

This multicenter, prospective, randomized-controlled study will compare the performance of the Nanotite vs. the standard Ossotite implants when placed by graduate students with little or no prior experience. Enrolled patients will have the study site(s) randomized to either a Nanotite (test) or an Osseotite (control) implant. The manner of treatment observed at the participating center will be followed for this study.

Study Hypothesis: The performance of the Nanotite implant in this study will be no different than or superior to that of the Osseotite implant placed during the early period of graduate student training.

02

Conditions studied

  • Tooth Disease
  • Partial Edentulism

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Keywords

  • dental implants
  • Nanotite implant
  • Osseotite implants
  • multicenter
  • randomized
  • clinical study
  • partial edentulism
  • prosthesis
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 241 is above 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 of any race, 18 years of age or older
  • patients for whom a decision has already been made to use dental implants for treating edentulism in the mandible or maxilla

Exclusion criteria

Exclusion Criteria:

  • patients who are known to be pregnant
05

Study design

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

Study arms

  • Experimental
    Nanotite implant

    Nanotite dental implant

    Device: Nanotite dental implant

  • Active comparator
    Osseotite implant

    Osseotite dental implant

    Device: Osseotite dental implant

Interventions

  • DeviceNanotite dental implant

    Nanotite root form titanium dental implant

    Also known as: Nanotite endosseous dental implant

  • DeviceOsseotite dental implant

    Osseotite Root form titanium dental implant

    Also known as: Osseotite endosseous dental implant

06

What researchers measure

Primary outcomes

  1. Integration Success of the Implant

    Time frame: 1 year

07

Results

Posted Feb 12, 2014

Participant flow

Up to 165 patients are expected to be enrolled across all centers, with enrollment efforts beginning in August 2008. Enrollment period remained opent until December 2010.

Participant flow — Overall Study
MilestoneNanotite ImplantOsseotite Implant
Started122119
Completed113112
Not completed97
Withdrew: Adverse event97

Outcome measures

PrimaryIntegration Success of the Implant
Time frame:
1 year
Reported as:
Number · implants
Integration Success of the Implant
implantsNanotite ImplantOsseotite Implant
Integration Success of the Implant230239

Adverse events

Collected over Adverse events are collected and reported throughout the duration of the study, an average of 2 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nanotite Implant—0/122 (0%)9/122 (7.4%)
Osseotite Implant—0/119 (0%)7/119 (5.9%)
Most frequent other events
Most frequent other events
EventNanotite ImplantOsseotite Implant
Loss of integration of implantSurgical and medical procedures9/1227/119

Baseline characteristics

Nanotite implants = 239 Osseotite implants = 246

Age, Categorical
Age, Categorical(Participants)Nanotite ImplantOsseotite ImplantTotal
<=18 years101
Between 18 and 65 years6163124
>=65 years6056116
Sex: Female, Male
Sex: Female, Male(Participants)Nanotite ImplantOsseotite ImplantTotal
Female6164125
Male6155116
08

Study locations

1 site
  • University of Alabama Birmingham
    Birmingham, Alabama 35294, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2008 to primary completion in Oct 2012, 54 months.

Results were first posted in Feb 2014, 1 year 4 months after primary completion.

Of 39 interventional studies with no phase under Tooth Diseases, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 42. This study's 54 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2008
First posted
Jul 31, 2008
StartActual
Apr 2008
Primary completionActual
Oct 2012
CompletionActual
Oct 2012
Results first posted
Feb 12, 2014
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00726063
Lead sponsor
ZimVie
Responsible party
Sponsor
First posted
Jul 31, 2008
Start date
Apr 2008
Primary completion
Oct 2012
Completion
Oct 2012
Results posted
Feb 12, 2014
Last update
Jul 28, 2026

Study contacts

Michael S Reddy, DMD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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