Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System

Completed · Not applicable

Conditions studied: Dental Implants, Alveolar Ridge Preservation

In brief

Randomized Controlled study to compare the effectiveness of two different treatment approaches using a new moldable beta-tricalcium phosphate(TCP) bone graft material in ridge preservation of an atraumatic extraction socket site compared to allograft with collagen plug.

Key facts

Study ID

NCT02702609

Run by

Sunstar Americas

People needed

45

Starts

2016-08-02

Expected to finish

2019-08-19

Last updated by the study team

2020-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of informed consent
• At least 18 years old
• In need of one posterior tooth, excluding third molar molars, planned for extraction and replacement with a dental implant (If the subject requires two adjacent socket preservation, they can still be enrolled in the study but only one site will be used for the study)
• Intact ridge as verified with cone-beam CT scan
• At least one natural tooth adjacent to the study site present.

You may not qualify if…

• Insufficient interocclusal space to allow for implant supported prosthesis
• Dehiscence or fenestration identified at the time of reviewing CBCT.
• Non-treated caries or uncontrolled periodontal disease present affecting the teeth in adjacent to study teeth.
• Any of natural teeth adjacent to the study site presents active periapical endodontic lesion ("active periapical endodontic lesion" will be determined per consultation by endodontics specialist).
• Adjacent tooth (mesial and distal) to study site was extracted within last 6 months
• Adjacent teeth (or tooth) to study site with significant soft tissue loss
• Smoker using more than 10 cigarettes or equivalent per day
• Smokeless tobacco use or e-cigarette use
• Current alcohol or drug abuser
• Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration e.g. uncontrolled diabetes
• Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
• Pregnancy, as indicated by positive serum human chorionic gonadotropin (HCG) test result.
• Unable or unwilling to return for follow-up visits for a period of 5 months
• Unlikely to be able to comply with study procedures according to Investigators judgement
• Subject in other clinical trials

Where it is running

• The University of Iowa College of Dentistry — Iowa City, Iowa, United States
• University of Maryland School of Dentistry — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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