A Histomorphometric Analysis Following Sinus Augmentation Using Two Different Bone Graft Materials.

Study Overview
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Brief Summary
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The purpose of this investigator-initiated study is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using two different bone graft materials. A total of twenty, sinus augmentation via a lateral approach will be performed for subjects requiring sinus augmentation for implant placement and randomly divided into 2 groups. These subjects will receive one of two different bone graft materials: 1) Anorganic bovine bone matrix- InterOss (Group A), 2) Anorganic bovine bone matrix- Bio-oss (Group B). At the time of implant placement (eight months after the sinus augmentation procedure), two bone biopsies will be collected from augmented site for the histomorphometric analysis. The percentage of vital bone will be measured and analyzed statistically, also the following will be measured: percentage of non-vital bone, percentage of non-bone material (xenograft), and the percentage of connective tissue.

Official Title
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A Histomorphometric Analysis of New Bone Formation Following Sinus Augmentation Using Two Different Bone Graft Materials. A Pilot Study in Humans.

Conditions
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Missing Teeth

Intervention / Treatment
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* Device: InterOss
* Device: Bio-oss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years old who are able to read and sign an informed consent form. Patient who has good oral hygiene (Full-mouth plaque score <25%). Subject would be available for study monitoring and follow-up visits. Patients with missing teeth in the maxillary posterior region who will require sinus augmentation for implant placement. The patients may be partially or completely edentulous. Patient is a candidate for delayed implant placement approximately 8 months following sinus grafting Exclusion Criteria: Alcohol, drug dependency. Signs or symptoms of chronic maxillary sinus disease. Current smoker. History of head and neck radiation treatment. Poor health, conditions like uncontrolled diabetes, uncontrolled hypertension or other uncontrolled systemic disease. Physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations. Also, subjects who are nursing or pregnant will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 103 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InterOss<br>Maxillary sinus augmentation using ABBM Inteross ( Xenograft) | Device: InterOss<br>* Anorganic bovine bone mineral - Xenograft<br>|
| Active Comparator: Bio-oss<br>Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft) | Device: Bio-oss<br>* Anorganic bovine bone mineral ( Xenograft)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of new vital bone | Vital bone as seen in histology | 8 months |