Clinical trial NCT02532543: Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tooth Fractures
Tooth Injuries
Tooth Diseases
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Dentsply International
First posted: 2015-08-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total Mean Change in Bone Volume
timeFrame: time of extraction to 3 months post extraction
Secondary outcomes:
measure: Mean Osseous Dimensional Changes-Horizontal
timeFrame: time of extraction to 3 months post extraction
measure: Mean Osseous Dimensional Changes-Vertical
timeFrame: time of extraction to 3 months post extraction
measure: Total Mean Change in Soft Tissue Volume
timeFrame: time of extraction to 3 months post extraction
measure: Mean Soft Tissue Dimensional Changes-Horizontal
timeFrame: time of extraction to 3 months post extraction
measure: Mean Soft Tissue Dimensional Changes-Vertical
timeFrame: time of extraction to 3 months post extraction
measure: Soft Tissue Dimensional Change at Month 6
timeFrame: Month 6
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina School of Dentistry
state: North Carolina
Study officials:
affiliation: Dept. of Periodontology
name: Jonathan Reside, DDS MS
role: PRINCIPAL_INVESTIGATOR
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