Ridge Preservation With Hardening Calcium Phosphate Bone Substitutes and Resorbable Membrane for Implant Site Development on Non-containable Extraction Sites: A Clinical and Histological Prospective Case Series in Humans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Change in Radiographic Measurements of Bone Ridge Dimensions
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Device treatment
easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane
Intervention: easy-graft CLASSIC (beta-Tricalcium Phosphate) (Device)
Outcomes
Primary Outcomes
Change in Radiographic Measurements of Bone Ridge Dimensions
Time Frame: 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)