A Clinical Investigation to Evaluate the Healing of Tooth Extraction Sites Filled With BioRestore™
|Alveolar Bone Loss||Device: Alveolar Bone Defect Regeneration Following Tooth Extraction||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Bone Regeneration by Means of a Bioactive Glass Scaffold.|
|Study Start Date:||December 2008|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
|Experimental: bioactive glass||
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.