An interventional study of Dental implant Osseotite Prevail and Dental implant Osseotite in Partial Edentulism and Tooth Disease, 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
This prospective, randomized study will evaluate the performance of the Osseotite Certain Prevail implant when compared to that of the non-lateralized version 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 a similar but non-lateralized Osseotite Certain implant.
This is a prospective, randomized, longitudinal study in which qualified patients with partial edentulism will receive a short-fixed bridge restoration. Each implant site is randomized to receive either the Osseotite Certain Lateralized (test) or the Osseotite Certain Non-lateralized (control). All implants will receive a temporary prosthesis after two months of placement. Enrollment will include up to 20 patients (approximately 60 implants per center) at each participating study center.
79 studies on the registry are indexed under Tooth Diseases; 11 are open to participants now.
This study's enrollment of 61 is above the median of 49 across 63 interventional studies indexed under Tooth Diseases.
Browse Tooth Diseases studies →ZimVie is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Dental implant with lateralized design
Device: Dental implant Osseotite Prevail
Dental implant without the lateralized design
Device: Dental implant Osseotite
Root form titanium dental implant
Also known as: Osseotite, Prevail
root form titanium dental implant
Also known as: Osseotite
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
Osseous Integration
Time frame: four years
Up to 120 patients were enrolled across all centers, with enrollment efforts beginning in February 2005. Enrollment period remained open until June 2006. Two participating sites were Universities and four were private practices.
| Milestone | Osseotite Certain Prevail Implant | Osseotite Certain Implant |
|---|---|---|
| Started | 29 | 32 |
| Completed | 29 | 32 |
| Not completed | 0 | 0 |
| Milestone | Osseotite Certain Prevail Implant | Osseotite Certain Implant |
|---|---|---|
| Started | 29 | 32 |
| Completed | 25 | 28 |
| Not completed | 4 | 4 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Lost to follow-up | 3 | 3 |
| Milestone | Osseotite Certain Prevail Implant | Osseotite Certain Implant |
|---|---|---|
| Started | 25 | 28 |
| Completed | 24 | 28 |
| Not completed | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Milestone | Osseotite Certain Prevail Implant | Osseotite Certain Implant |
|---|---|---|
| Started | 24 | 28 |
| Completed | 24 | 28 |
| Not completed | 0 | 0 |
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.
| millimeters | Osseotite Certain Prevail Implant | Osseotite Certain Implant |
|---|---|---|
| Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit | -0.7440 ± 0.1881 | -0.8445 ± 0.1439 |
Results for this outcome have not been posted.
Collected over Adverse events are collected and reported from day 1 of the study to present, 4 years of study duration to date.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Osseotite Certain Prevail Implant | — | 0/29 (0%) | 5/29 (17.2%) |
| Osseotite Certain Implant | — | 0/32 (0%) | 5/32 (15.6%) |
| Event | Osseotite Certain Prevail Implant | Osseotite Certain Implant |
|---|---|---|
| Loss of integration of implantSurgical and medical procedures | 5/29 | 5/32 |
| Age, Customized(participants) | Osseotite Certain Prevail Implant | Osseotite Certain Implant | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 21 | 39 |
| >=65 years | 11 | 11 | 22 |
| Sex/Gender, Customized(participants) | Osseotite Certain Prevail Implant | Osseotite Certain Implant | Total |
|---|---|---|---|
| Female | 14 | 15 | 29 |
| Male | 15 | 17 | 32 |
| Region of Enrollment(participants) | Osseotite Certain Prevail Implant | Osseotite Certain Implant | Total |
|---|---|---|---|
| United States | 6 | 8 | 14 |
| Italy | 15 | 15 | 30 |
| Sweden | 5 | 4 | 9 |
| Australia | 3 | 5 | 8 |
Plan to share: No
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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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