An interventional study of Dental Implant (Osseotite) in Tooth Disease and Partial Edentulism, sponsored by ZimVie. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by ZimVie · Not applicable, Interventional, and Treatment
This prospective, randomized-controlled, clinical study evaluates the ability of the NanoTite implant system to achieve integration and provide long-term support of a prosthesis when placed immediately in fresh sinus augmentation material. Control cases will be those where the sinus augmentation material is allowed four months of healing prior to NanoTite implant placement. In addition to implant performance, radiographic evidence of crestal bone regressive modeling will be used to evaluate differences between test and control cases.
Study (null) hypothesis: The implants placed into sinus augmentation sites at the time of grafting will have the same integration success and maintenance of integration as for the implants placed after four months of graft healing.
This will be a prospective, randomized-controlled, longitudinal study in which qualified patients with partial edentulism and thin maxillary ridges will have as part of their treatment at least one sinus ridge augmentation procedure and have their edentulism restored with an implant-supported short-span or long-span fixed bridge. Each patient may have up to two cases included in the study should they need bilateral sinus augmentation using unilateral bridge restorations on either side.
Each patient (or side if a bilateral case) will be randomly assigned to one of two groups: Treatment Group 1 (test) cases will have implants placed into the sinus cavity during the graft augmentation procedure. Treatment Group 2 (control) will have a sinus lift augmentation and implant placement into this area will take place after four months of graft healing. For both groups the implants will be submerged and allowed four months of healing before second stage surgery.
79 studies on the registry are indexed under Tooth Diseases; 11 are open to participants now.
This study's enrollment of 122 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 implants placed simultaneously with graft augmentation material.
Device: Dental Implant (Osseotite)
Dental implants placed into graft augmentation material that has four months to heal.
Root form titanium dental implant
Also known as: Osseotite
Implants Not Mobile (Not Failing) at End of 3 Years
All surviving implants at the end of study (3 years)
Time frame: 3 years
Crestal Bone Loss (Measured Value of Bone Level Around the Dental Implant)
Average measured bone loss (change from baseline) for each implant placed at 3 years final time frame
Time frame: 3 year
Patients enrolled in the study according to inclusion/ exclusion criteria as described in the protocol. Patient enrollment began September 2006 and ended May 2008.
| Milestone | Treatment Group | Control Group |
|---|---|---|
| Started | 65 | 57 |
| Completed | 60 | 53 |
| Not completed | 5 | 4 |
| Withdrew: Lost to follow-up | 4 | 4 |
| Withdrew: Death | 1 | 0 |
All surviving implants at the end of study (3 years)
| dental implant | Treatment Group | Control Group |
|---|---|---|
| Implants Not Mobile (Not Failing) at End of 3 Years | 158 | 140 |
Average measured bone loss (change from baseline) for each implant placed at 3 years final time frame
Results for this outcome have not been posted.
Collected over Adverse events are collected and reported from day 1 up to 3 years (end of the study). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | — | 0/65 (0%) | 2/65 (3.1%) |
| Control Group | — | 0/57 (0%) | 1/57 (1.8%) |
| Event | Treatment Group | Control Group |
|---|---|---|
| MobilitySurgical and medical procedures | 2/65 | 1/57 |
| Age, Categorical(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 60 | 23 | 83 |
| >=65 years | 2 | 7 | 9 |
| Sex: Female, Male(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Female | 28 | 17 | 45 |
| Male | 34 | 13 | 47 |
| Region of Enrollment(participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Italy | 44 | 19 | 63 |
| Spain | 9 | 5 | 14 |
| Portugal | 9 | 6 | 15 |
Plan to share: No
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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