Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials
Status: | Recruiting |
---|---|
Conditions: | Dental |
Therapuetic Areas: | Dental / Maxillofacial Surgery |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 10/26/2018 |
Start Date: | April 2016 |
End Date: | March 2020 |
Contact: | Gidgetta E Jenkins, CCRC |
Email: | Gidget_Jenkins@dentistry.unc.edu |
Phone: | 919-537-3968 |
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
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.
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.
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
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Phone: 919-537-3968
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