Maxillary Sinus, Sinus Floor Augmentation
Conditions
Keywords
Sinus Floor Augmentation, Maxillary Sinus, Bone Substitutes, Bone Regeneration
Brief summary
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.
Interventions
PROCEDURECalcium phosphosilicate alloplastic bone putty in direct sinus augmentation
PROCEDUREAnorganic bovine bone mineral in direct sinus augmentation
Sponsors
NovaBone Products, LLC
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with non-contributory medical history that will present for bilateral sinus lift surgery prior to implant placement
Exclusion criteria
* Patients that will not agree to participate in this study or sign the consent form * More than 8mm of residual bone height at the implant site * Subjects smoking more than 10 cigarettes per day * History of acute sinus infection * History of prior maxillary sinus surgery (Caldwell-Luc, direct or indirect sinus lift, etc) * Medications that affect bone healing (chronic steroid regimen, oral or IV bisphosphonates, etc.) * Patients allergic to bovine derivatives * Patients who are a carrier of transmissible disease(s) that may unnecessarily expose laboratory personnel to risks * Females during pregnancy or lactation or females that plan to become pregnant in the following year (pregnancy test prior to enrollment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of new bone growth in the maxillary sinus | 7 months(plus minus 1 month) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gain in vertical bone height | 6 months (plus or minus 1month) | 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. |
| Radiographic bone density | 6 months (plus or minus 1 month) | 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. |
| Primary implant stability | 7 months (plus or minus 1 month) | Primary stability of implants placed in the augmented sinuses will be evaluated as a clinical index of bone density. |
| Marginal bone level maintenance | 12 months(plus or minus 1 month) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implant success | 2nd stage, 6&12 months post-loading | Patients will be evaluated for clinical symptoms and implant success using predetermined criteria. |
Countries
United States
Outcome results
None listed