Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study

Conditions
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Sinus Floor Augmentation, Maxillary Sinus

Intervention / Treatment
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* Procedure: Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation
* Procedure: Anorganic bovine bone mineral in direct sinus augmentation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anorganic bovine bone mineral in direct sinus augmentation<br>Anorganic bovine bone mineral | Procedure: Anorganic bovine bone mineral in direct sinus augmentation<br> <br> |
| Experimental: Alloplastic bone putty in direct sinus augmentation<br>Alloplastic bone putty | Procedure: Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinus Floor Augmentation, Maxillary Sinus, Bone Substitutes, Bone Regeneration