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

• easy-graft CLASSIC (beta-Tricalcium Phosphate) (Device), also known as GUIDOR Bioresorbable Matrix Barrier: easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.

Primary outcomes

• Change in Radiographic Measurements of Bone Ridge Dimensions [Change from Baseline at 3 months]: Cone-beam computed tomography (CBCT) was taken at the ridge preservation procedure (baseline) and 3 months after the procedure. The horizontal ridge width was measured at 1, 3, 5 and 7 mm below the alveolar bone crest. Overall change is the average of all measurements.

Secondary outcomes

• Change in Digital Measurements of Soft Tissue Dimensions [Change from baseline at 5 months]: Pre- and post-surgery casts were made from impressions and scanned with a digital scanner. The soft tissue width was measured at 1, 3 and 5 mm below the ridge crest. Overall change is the average of all measurements.

Sex: All, ages: 18 Years to any

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)

Participant flow

Outcome results

• Change in Radiographic Measurements of Bone Ridge Dimensions (Primary), Mean, mm: Device Treatment 1.59 +/- 1.05
• Change in Digital Measurements of Soft Tissue Dimensions (Secondary), Mean, mm: Device Treatment 0.99 +/- 2.18

Adverse events

Time frame: 5 months after ridge preservation surgery

• Study Protocol and Statistical Analysis Plan (PDF, 2017-06-29)