Bone Regeneration by Means of a Bioactive Glass Scaffold.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Trieste
- Enrollment
- 14
Study Overview
Brief Summary
The aim of this study was to evaluate by histology and MSCT scans during a 7-month period, the efficacy of a bioactive glass (Inion BioRestore™) placed in human extraction sockets in the maintenance of alveolar ridge.
Detailed Description
14 subjects in need of implant therapy were enrolled in the study. A total of 32 teeth were extracted and the fresh sockets underwent to ridge preservation procedures using Inion BioRestore™. Two different time points (1 week and 3 months after RPP) MSCT scans for each patient were used as a basis for bone change analysis occurred in the localized grafted alveolar sites. Twenty-two biopsied, representative of intermediate (3-4 months, n=10) and late phase (6-7 months, n=12) of healing, were harvested and histologically analysed.
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
- Yes
Inclusion Criteria
- •Systemically healthy females or males subjects.
- •They did not smoke
- •Did not take any medications.
Exclusion Criteria
- •Subjects with less than 18 years of age,
- •with current alcohol or drug abuse,
- •with systemic/local conditions that would interfere with wound healing or osseointegration
- •with a history of chemotherapy and radiotherapy in the head and neck region.