A Clinical Investigation to Evaluate the Healing of Tooth Extraction Sites Filled With BioRestore™
- Conditions
- Alveolar Bone Loss
- Registration Number
- NCT01105026
- Lead Sponsor
- University of Trieste
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Systemically healthy females or males subjects.
- They did not smoke
- Did not take any medications.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method