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

Stopped early · Not applicable

Conditions studied: Tooth Fractures, Tooth Injuries, Tooth Diseases

In brief

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.

Key facts

Study ID

NCT02532543

Run by

University of North Carolina, Chapel Hill

People needed

16

Starts

2016-04-01

Expected to finish

2018-02-12

Last updated by the study team

2019-12-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of North Carolina School of Dentistry — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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