A Clinical Investigation to Evaluate the Healing of Tooth Extraction Sites Filled With BioRestore™

University of Trieste

Status and phase

Completed

Phase 1

Conditions

Alveolar Bone Loss

Treatments

Device: Alveolar Bone Defect Regeneration Following Tooth Extraction

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01105026

CBT-109-CT

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.