Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation

Study Overview
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Brief Summary
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The purpose of this clinical trial is to assess if the addition of DFDBA fibers to DBBM results in greater vital bone formation than the addition of DFDBA particles to DBBM. The study team will examine the effects of the addition of DFDBA fibers to DBBM on vital bone formation. Specifically, we will assess histologically the percent vital bone formation with each of the groups during implant placement, six months after the sinus augmentation procedure. We will also evaluate the radiographic volume achieved with both groups of materials.

Detailed Description
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This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing maxillary sinus augmentation will be enrolled. There will be two subject groups in this study both of which will randomized to one of two standard care procedures. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups a bone sample (core) will be obtained as a by-product of implant placement. Bone will not be extracted solely for research purposes, the bone sample attained for research will only be from bone left over after the SOC implant placement. Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.

Official Title
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Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation: A Double Arm Randomized Control And Histomorphometric Study

Conditions
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Bone Loss in Jaw

Intervention / Treatment
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* Device: DFDBA fibers
* Device: DFDBA particles
* Device: DBBM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between age 18 and 89 Patients needing sinus augmentation to support implant placement in the posterior maxilla Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential. Exclusion Criteria: Patients who disclose that they will not be able to cooperate with the follow-up schedule. Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report) Pregnant women or women intending to become pregnant during study period Smokers who smoke > 10 cigarettes per day

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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
Interventional Model Description: This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DFDBA Fibers with DBBM<br>After standard of care elevation of the Schneiderian membrane, a mix of DFDBA fibers with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla. | Device: DFDBA fibers<br>* Bone Allograft fibers used in dental sinus reconstruction surgery<br>* Other names: Demineralized Freeze Dried Bone Allograft Fibers;Device: DBBM<br>* DBBM is routinely used in sinus augmentation to support dental implant placement and restoration of missing teeth.<br>* Other names: Deproteinized Bovine Bone Mineral;|
| Other: DFDBA Particles with DBBM<br>After standard of care elevation of the Schneiderian membrane, a mix of DFDBA particles with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla. | Device: DFDBA particles<br>* Bone Allograft particles used in dental sinus reconstruction surgery<br>* Other names: Demineralized Freeze Dried Bone Allograft Particles;Device: DBBM<br>* DBBM is routinely used in sinus augmentation to support dental implant placement and restoration of missing teeth.<br>* Other names: Deproteinized Bovine Bone Mineral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Vital Bone Formation | Each side of the maxillary sinus will be used as a separate unit of analysis. The assumption is that each patient will have only one side of the maxillary sinus; however, it is common for some patients to need both maxillary sinuses augmented (2 sites in a single patient). Change in vital bone formation will be measured from baseline (surgery) to 6 months post surgery. | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth loss, Bone Resorption, Xenograft, Allograft