Bone Augmentation Techniques in Extraction Sockets

Study Overview
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Brief Summary
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The study will compare the density and strength of regenerated bone in extraction sockets after being grafted with two different materials: Bone Allograft and Bone Allograft with Amnion. The investigators hypothesize that sockets grafted with the Amnion graft will exhibit enhanced healing patterns and will accelerate the formation of regenerated bone in the grafted areas.

Detailed Description
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The amniotic allograft is a cryopreserved allograft tissue matrix derived from human placental tissues recovered from live healthy donors. Amniotic tissue is an abundant source of collagen which provides an extracellular matrix to act as a natural scaffold for cellular attachment in the body; collagen provides a structural tissue matrix that facilitates cellular migration and proliferation in-vivo. The product is developed using proprietory techniques by BioDlogics, LLC. The amniotic allograft growth factors are thought to enhance formation of a supportive scaffold for regeneration, to facilitate interactions between cell types, and to influence anti-inflammatory, anti-microbial and immuno-privilege activities. Atraumatic extractions and socket grafts will be performed. Dental implants will be inserted into the grafted areas 8 weeks post-graft. The implants will be restored and followed for 24 months post-insertion.

Official Title
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A Prospective Study of Bone Augmentation Techniques in Extraction Sockets

Conditions
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Tooth Loss

Intervention / Treatment
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* Other: Amnion Allograft
* Other: Allograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be a registered University of Alabama at Birmingham (UAB) dental school patient Existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction Healthy enough to undergo the proposed therapy Demonstrated willingness to comply with study directions and time-line Able to consent for themselves Able to read and understand the informed consent form - Exclusion Criteria: Pregnant or lactating at the time of enrollment Previous Malignant neoplasm Known hypersensitivity to bone grafting materials Know hypersensitivity to titanium Any medical of medication that in the opinion of the investigators may adversely affect bone healing Any indication of an inability to make autonomous decisions -

Ages Eligible for Study
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Minimum Age: 19 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: Amnion Allograft<br>Atraumatic tooth extractions and amnion allograft procedures | Other: Amnion Allograft<br>* Atraumatic extraction and grafting procedures will be followed by insertion of a dental implant into the grafted area at week-8. The implant will be restored and be monitored for 24 months post-insertion. Two special dental cone-beam CT images (pre-baseline and week-7) and a minimum of 6 intraoral radiographs will be taken during the study<br>|
| Active Comparator: Allograft<br>Atraumatic tooth extractions and allograft procedures | Other: Allograft<br>* Atraumatic extraction and grafting procedures will be followed by insertion of a dental implant into to the grafted area at week-8. The implant will be restored and be monitored for 24 months post-insertion. Two special dental cone-beam CT images (pre-baseline and week-7) and a minimum of 6 intraoral radiographs will be taken during the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Hard Tissue Composition | A biopsy will be harvested from each grafted-site and sent to a laboratory for histological and histomorphometric analysis | baseline, week-8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in soft tissue healing | Clinical examination utilizing photographic data and imaging analysis software | baseline, 7 weeks, 12 months, 24 months, | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allograft, Amnion Allograft