Ridge Preservation With Moldable Beta-tricalcium Phosphate Bone Substitute on Non-containable Non-Molar Extraction Sites

Sunstar

Status

Terminated

Conditions

Dental Implants

Alveolar Ridge Preservation

Treatments

Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03215667

CLP-2016-11-07-1

Details and patient eligibility

About

Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth with non-containable extraction sockets.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adequate restorative space for a dental implant restoration, if the subject decides previous to study participation that they would like an implant. Note, agreement to implant placement is not a requirement of the study
minimum of 10-mm vertical bone without impinging on adjacent vital structures (Maxillary sinus, neurovascular bundles)
single-rooted tooth to be extracted
American Society of Anesthesiologists (ASA) Physical Status Classification I or II
age >18 years old
subjects who had >50% of height on any portion on the buccal wall of dehiscence and/or fenestration of the extraction socket following extraction will be included from this study
adjacent teeth to extraction site will be present during healing period
willingly sign informed consent and authorization.

Exclusion criteria

do not meet any inclusion criteria
pregnancy or nursing woman
subjects with active systemic or localized infection (exclude chronic periodontitis)
subjects with a history of any medical conditions that contraindicated or weighed against dental implant placement such as history of bisphosphonate drug use, chemotherapeutic or immunosuppressive agents, autoimmune disease, or poorly controlled diabetes (HBA1c>7%)
subjects with smoking habit (more than 10 cigarettes per day)