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CompletedNCT00723944RadioCityUpdated Jul 28, 2026Results posted

A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases

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

Sponsored by ZimVie · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This prospective, randomized study evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design of the implant.

Study (null) hypothesis: the crestal bone changes that take place after placement and loading of the Osseotite lateralized implants will be the same as for similar but non-lateralized Osseotite Certain implants.

Read the detailed description

This is a prospective, randomized-controlled study where patients with qualifying partial edentulism received a short fixed bridge restoration. Each implant site was randomized to receive either the test (Osseotite Certain Prevail) or the control non lateralized version of the Osseotite Certain implant. All implants were placed in a single-stage manner with temporary provisionalization taking place two months after implant placement. Enrollment continued until 10 patients (approximately 30 implants) were treated at each participating study center.

02

Conditions studied

  • Partial Edentulism
  • Tooth Disease

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Keywords

  • dental implants
  • Osseotite Certain Prevail
  • Lateralized
  • non-lateralized
  • Osseotite Certain
  • multicenter
  • randomized
  • clinical study
  • partial edentulism
  • single stage
  • early loading
  • crestal bone level
  • short fixed bridge
03

Who can participate

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

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 treating an existing dental condition specifically: a partially edentulous short fixed case of less than 4 implants in the maxilla or mandible; no cantilevers are allowed, but one interior crown may be a pontic
  • 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 visit

Exclusion criteria

Exclusion Criteria:

  • patients with active infection or severe inflammation in the areas intended for the implants
  • patients with more than 10 cigarette per day smoking habit
  • patients with uncontrolled diabetes mellitus
  • patients with metabolic bone disease
  • patients who have had treatment with therapeutic radiation to the head within the past 12 months
  • patients in need of allogenic bone grafting at the site of the intended study implant
  • patients who are pregnant at the screening visit
  • patients with evidence of severe para-functional habits such as bruxing or clenching
  • patients with cantilevers and more than one pontic per bridge
04

Study design

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

Study arms

  • Active comparator
    Osseotite Certain Prevail

    Dental implant with lateralized design

    Device: Osseotite Certain Prevail

  • Placebo comparator
    Osseotite Certain

    Dental implant without the lateralized design

    Device: Osseotite Certain

Interventions

  • DeviceOsseotite Certain Prevail

    Root form titanium dental implant

    Also known as: Osseotite, Certain, Prevail

  • DeviceOsseotite Certain

    Dental implant without the lateralized design

    Also known as: Osseotite, Certain

05

What researchers measure

Primary outcomes

  1. Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit

    Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.

    Time frame: 1 year

Secondary outcomes

  1. Osseous Integration

    Time frame: 4 years

06

Results

Posted Nov 22, 2011

Participant flow

A minimum of 100 patients were enrolled across all participating centers, with enrollment beginning in January 2005. Enrollment period remained open until April 2006. Three participating sites were Universities and seven were private practices.

Implant Placement Surgery
Participant flow — Implant Placement Surgery
MilestoneOsseotite Certain Prevail ImplantOsseotite Certain Implant
Started5250
Completed5250
Not completed00
Permanent Prosthesis Placement
Participant flow — Permanent Prosthesis Placement
MilestoneOsseotite Certain Prevail ImplantOsseotite Certain Implant
Started5250
Completed4941
Not completed39
Withdrew: Adverse event17
Withdrew: Lost to follow-up22
One year post placement follow-up
Participant flow — One year post placement follow-up
MilestoneOsseotite Certain Prevail ImplantOsseotite Certain Implant
Started4941
Completed4837
Not completed14
Withdrew: Lost to follow-up14
Two year post placement follow-up
Participant flow — Two year post placement follow-up
MilestoneOsseotite Certain Prevail ImplantOsseotite Certain Implant
Started4837
Completed4837
Not completed00

Outcome measures

PrimaryCrestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit

Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.

Time frame:
1 year
Reported as:
Mean · millimeters
Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit
millimetersOsseotite Certain Prevail ImplantOsseotite Certain Implant
Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit-0.7705 ± 0.1567-0.6648 ± .1158
SecondaryOsseous Integration
Time frame:
4 years

Results for this outcome have not been posted.

Adverse events

Collected over Adverse event reporting is collected from day of the study to present, currently 4 years study duration.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Osseotite Certain Prevail Implant—0/52 (0%)4/52 (7.7%)
Osseotite Certain Implant—0/50 (0%)19/50 (38%)
Most frequent other events
Most frequent other events
EventOsseotite Certain Prevail ImplantOsseotite Certain Implant
Loss of implant integrationSurgical and medical procedures4/5219/50

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Osseotite Certain Prevail ImplantOsseotite Certain ImplantTotal
<=18 years000
Between 18 and 65 years403878
>=65 years121224
Sex: Female, Male
Sex: Female, Male(Participants)Osseotite Certain Prevail ImplantOsseotite Certain ImplantTotal
Female211940
Male313162
Region of Enrollment
Region of Enrollment(participants)Osseotite Certain Prevail ImplantOsseotite Certain ImplantTotal
United States141630
Italy191736
France6511
Germany8816
Sweden549
07

Study locations

1 site
  • Charite- Universitatsmedizin Berlin
    Berlin, D-10117, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Registry details

Key details

Study ID
NCT00723944
Lead sponsor
ZimVie
Responsible party
Sponsor
First posted
Jul 29, 2008
Start date
Feb 2005
Primary completion
Apr 2007
Completion
May 2011
Results posted
Nov 22, 2011
Last update
Jul 28, 2026

Study contacts

Anton Friedmann, DMD
principal investigator · Charite- Zentrum fur Zahnmedizin

Oversight

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

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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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