Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials

Study Overview
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Brief Summary
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This study is intended to provide statistically robust evidence that Symbios Demineralized Cortical-cancellous granule mix, Symbios OsteoGraf LD-300, and OsteoGraf/N-300 combined with Symbios OsteoShield Collagen Resorbable Membrane can adequately support the alveolus during ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the overlying soft tissues. Additionally, a comparison between each material will be made, providing further evidence of each materials' ability to preserve the alveolus. It is intended to define in objective terms the response of the hard and soft tissues to ridge augmentation.

Official Title
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Prospective, Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials (SYMBIOS CORTICAL-CANCELLOUS GRANULE MIX; SYMBIOS OSTEOGRAF LD-300; OSTEOGRAF/N-300) Following Tooth Extraction

Conditions
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Tooth Fractures, Tooth Injuries, Tooth Diseases

Intervention / Treatment
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* Biological: Allograft, Membrane
* Biological: Alloplast, Membrane
* Biological: Xenograft, Membrane
* Biological: Membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent ≥ 18 years and ≤ 75 years Good physical health (ASAI/II) Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required Teeth adjacent (mesial and distal) to study site must consist of two stable natural teeth with minimal restorations, without signs of periodontal bone loss (> 3 mm) and/or significant soft tissue deficiencies Exclusion Criteria: Buccal plate dehiscence and/or fenestration >3mm at study site following extraction Untreated rampant caries and uncontrolled periodontal disease Inadequate oral hygiene (estimated plaque score >20%) Smokers using more than 10 cigarettes or equivalent per day Smokeless tobacco use or e-cigarette use Compromised physical health and/or uncontrolled or severe systemic diseases including: ASA III/IV Metabolic bone disease History of malignancy History or radiotherapy or chemotherapy for malignancy in the past 5 years History of autoimmune disease Long-term steroidal or antibiotic therapy Uncontrolled diabetes Known alcohol or drug abuse Systemic or local disease or condition that would compromise post-operative healing Use of any substance or medication that will influence bone metabolism Known pregnancy Unable or unwilling to return for follow-up visits for a period of 6 months Unlikely to be able to comply with study procedures according to Investigators judgement Involvement in the planning and conduct of the study Previous enrollment or randomization of treatment in the present study

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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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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A- Allograft, Membrane<br>Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane | Biological: Allograft, Membrane<br>* Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane<br>|
| Active Comparator: Group B- Alloplast, Membrane<br>Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane | Biological: Alloplast, Membrane<br>* Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane<br>|
| Active Comparator: Group C- Xenograft, Membrane<br>OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane | Biological: Xenograft, Membrane<br>* Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane<br>|
| Active Comparator: Group D- Membrane<br>Symbios OsteoShield Collagen Resorbable Membrane | Biological: Membrane<br>* Membrane - Symbios OsteoShield Collagen Resorbable Membrane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Mean Change in Bone Volume | The change in bone volume at 3 months following extraction will be calculated using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software | time of extraction to 3 months post extraction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Osseous Dimensional Changes-Horizontal | The amount of linear (mm) horizontal bone change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal plate. Data will be calculated using data from DICOM images acquired by CBCT using 3D software. | time of extraction to 3 months post extraction | 
| Mean Osseous Dimensional Changes-Vertical | The amount of linear (mm) vertical bone change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from DICOM images acquired by CBCT using 3D software. | time of extraction to 3 months post extraction | 
| Total Mean Change in Soft Tissue Volume | The change in soft tissue volume at 3 months following tooth extraction will be assessed through the use of 3D scans of patient dental models at two time points following extraction and ridge preservation at 3 months. | time of extraction to 3 months post extraction | 
| Mean Soft Tissue Dimensional Changes-Horizontal | The amount of linear (mm) horizontal soft tissue change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal bone plate. Data will be calculated using data from DICOM images acquired by CBCT and overlaid 3D scans of patient dental models using 3D software. | time of extraction to 3 months post extraction | 
| Mean Soft Tissue Dimensional Changes-Vertical | The amount of linear (mm) vertical soft tissue change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from 3D scans of patient dental models using 3D software. | time of extraction to 3 months post extraction | 
| Soft Tissue Dimensional Change at Month 6 | The amount of soft tissue change will be assessed through the use of dental casts at two time points following extraction and ridge preservation at 6 months. | Month 6 |