NCT01105026

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

Bone Regeneration by Means of a Bioactive Glass Scaffold.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Trieste · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alveolar Bone Loss

Interventions

Type	Name	Description
DEVICE	Alveolar Bone Defect Regeneration Following Tooth Extraction	Patients underwent surgery under local anesthesia and minimally invasive periotomy was carried out with a surgical blade. Atraumatic extraction with forceps was performed. The extraction socket was carefully curetted to remove the granulation tissue and was rinsed with a physiologic solution. To evaluate the eligibility of the surgical site, the alveolar walls integrity was checked clinically and by means of extemporaneous peri-apical radiography. Then, the socket was filled to the bone margin with Inion BioRestore™ (granules size 1 to 2 millimetres). Finally, single interrupted (5-0) sutures were tightened to promote the stability of grafted particles. Ten days after the surgery, sutures were removed.

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2010-04-16
• Last updated: 2010-04-16