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

University of North Carolina, Chapel Hill16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tooth Fractures Tooth Injuries Tooth Diseases

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Provision of informed consent 2. ≥ 18 years and ≤ 75 years 3. Good physical health (ASAI/II) 4. Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required 5. 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: 1. Buccal plate dehiscence and/or fenestration \>3mm at study site following extraction 2. Untreated rampant caries and uncontrolled periodontal disease 3. Inadequate oral hygiene (estimated plaque score \>20%) 4. Smokers using more than 10 cigarettes or equivalent per day 5. Smokeless tobacco use or e-cigarette use 6. 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 7. Systemic or local disease or condition that would compromise post-operative healing 8. Use of any substance or medication that will influence bone metabolism 9. Known pregnancy 10. Unable or unwilling to return for follow-up visits for a period of 6 months 11. Unlikely to be able to comply with study procedures according to Investigators judgement 12. Involvement in the planning and conduct of the study 13. Previous enrollment or randomization of treatment in the present study

Outcomes

Primary Outcomes

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