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| Name | Class |
|---|---|
| NovaBone Products, LLC | INDUSTRY |
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The purpose of this split-mouth clinical study is to evaluate the clinical, radiographic and histological outcomes of lateral window sinus augmentation with a bovine xenograft or a CPS putty bone substitute in posterior maxillary sites and the survival of implants placed in these sites following healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anorganic bovine bone mineral in direct sinus augmentation | Active Comparator | Anorganic bovine bone mineral |
|
| Alloplastic bone putty in direct sinus augmentation | Experimental | Alloplastic bone putty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation | Procedure |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of new bone growth in the maxillary sinus | Difference between the percentage of new bone growth between the two groups as determined by histomorphometric analysis of bone cores retrieved during implant placement surgery. | 7 months(plus minus 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Gain in vertical bone height | Patients will be seen for radiographic evaluation post-sinus surgery. A cone beam computed tomography (CBCT) will be obtained and a blinded investigator will evaluate the vertical bone height at the sites. | 6 months (plus or minus 1month) |
| Radiographic bone density |
| Measure | Description | Time Frame |
|---|---|---|
| Implant success | Patients will be evaluated for clinical symptoms and implant success using predetermined criteria. | 2nd stage, 6&12 months post-loading |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georgios A Kotsakis, DDS | University of Minnesota | Principal Investigator |
| James E Hinrichs, DDS, MS | University of Minnesota | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Education in Periodontology Clinic, Dental School, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12381063 | Background | Hallman M, Sennerby L, Lundgren S. A clinical and histologic evaluation of implant integration in the posterior maxilla after sinus floor augmentation with autogenous bone, bovine hydroxyapatite, or a 20:80 mixture. Int J Oral Maxillofac Implants. 2002 Sep-Oct;17(5):635-43. | |
| 15626319 | Background | Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77. |
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| Anorganic bovine bone mineral in direct sinus augmentation |
| Procedure |
|
Patients will be seen for radiographic evaluation. A cone beam computed tomography(CBCT) will be obtained and a blinded investigator will evaluate the volumetric grey values at each site as an index of bone quality. |
| 6 months (plus or minus 1 month) |
| Primary implant stability | Primary stability of implants placed in the augmented sinuses will be evaluated as a clinical index of bone density. | 7 months (plus or minus 1 month) |
| Marginal bone level maintenance | Intraoral radiographs, using a paralleling technique, with customized film holders will be obtained at baseline (time of abutment connection) and at the 12-month follow-up visit and evaluated by an independent investigator to assess marginal bone levels around the implant platform. The measurements will be performed mesially and distally of each implant. | 12 months(plus or minus 1 month) |
| 23772806 | Background | Mahesh L, Venkataraman N, Shukla S, Prasad H, Kotsakis GA. Alveolar ridge preservation with the socket-plug technique utilizing an alloplastic putty bone substitute or a particulate xenograft: a histological pilot study. J Oral Implantol. 2015 Apr;41(2):178-83. doi: 10.1563/AAID-JOI-D-13-00025. Epub 2013 Jun 17. |