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

Not Applicable

Terminated

Conditions: Tooth Injuries
Tooth Fractures
Tooth Diseases

Interventions: Biological: Allograft, Membrane
Biological: Alloplast, Membrane
Biological: Xenograft, Membrane
Biological: Membrane

Registration Number: NCT02532543

Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A- Allograft, Membrane	Allograft, Membrane	Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Group B- Alloplast, Membrane	Alloplast, Membrane	Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Group C- Xenograft, Membrane	Xenograft, Membrane	OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Group D- Membrane	Membrane	Symbios OsteoShield Collagen Resorbable Membrane

Primary Outcome Measures

Name	Time	Method
Total Mean Change in Bone Volume	time of extraction to 3 months post extraction	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

Secondary Outcome Measures

Name	Time	Method
Mean Soft Tissue Dimensional Changes-Vertical	time of extraction to 3 months post extraction	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.
Mean Osseous Dimensional Changes-Vertical	time of extraction to 3 months post extraction	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.
Mean Osseous Dimensional Changes-Horizontal	time of extraction to 3 months post extraction	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.
Total Mean Change in Soft Tissue Volume	time of extraction to 3 months post extraction	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.
Mean Soft Tissue Dimensional Changes-Horizontal	time of extraction to 3 months post extraction	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.
Soft Tissue Dimensional Change at Month 6	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.