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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dental implant (Osseotite) | Active Comparator | Dental implants placed simultaneously with graft augmentation material. |
|
| Control group | No Intervention | Dental implants placed into graft augmentation material that has four months to heal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental Implant (Osseotite) | Device | Root form titanium dental implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implants Not Mobile (Not Failing) at End of 3 Years | All surviving implants at the end of study (3 years) | 3 years |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergio Caputi, DDS | Director del Dipartimento di Scienze Odontostomatologiche | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università "G. d' Annunzio" Chieti-Pescara | Chieti | Italy |
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Patients enrolled in the study according to inclusion/ exclusion criteria as described in the protocol. Patient enrollment began September 2006 and ended May 2008.
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Dental implants placed simultaneously with graft augmentation material. |
| FG001 | Control Group | Dental implants placed into graft augmentation material that has four months to heal. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Dental implants placed simultaneously with graft augmentation material. |
| BG001 | Control Group | Dental implants placed into graft augmentation material that has four months to heal. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Implants Not Mobile (Not Failing) at End of 3 Years | All surviving implants at the end of study (3 years) | dental implants | Posted | Number | dental implant | 3 years | dental implant | dental implant |
|
Adverse events are collected and reported from day 1 up to 3 years (end of the study)
Adverse event data is collected by patient questioning and visual examination of patient's mouth during each study visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Dental implants placed simultaneously with graft augmentation material. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mobility | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Biomet 3i LLC | 5617766722 | cristina.matthews@biomet.com |
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| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| dental implant |
|
|
| Other Pre-specified | 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 | Not Posted | Jul 2024 | 3 year | Participants |
| 0 |
| 65 |
| 2 |
| 65 |
| EG001 | Control Group | Dental implants placed into graft augmentation material that has four months to heal. | 0 | 57 | 1 | 57 |
PI shall furnish SPONSOR with a copy of any proposed publication thirty (30) days prior to submission for publication for review and comment. SPONSOR may request PI to delay publishing such proposed publication for a maximum of an additional sixty (60) days in order to protect the potential patentability of any invention described therein.
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |