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Clinical Trials/NCT01105026
NCT01105026
Completed
Phase 1

Bone Regeneration by Means of a Bioactive Glass Scaffold.

University of Trieste0 sites14 target enrollmentDecember 2008

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Alveolar Bone Loss
Sponsor
University of Trieste
Enrollment
14
Status
Completed
Last Updated
16 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
November 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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