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

Sunstar

Status

Completed

Conditions

Dental Implants

Alveolar Ridge Preservation

Treatments

Device: FDBA with collagen plug

Device: easy-graft CLASSIC

Study type

Interventional

Funder types

Industry

Identifiers

NCT02702609

CLP-2015-12-17-1

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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