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

Alveolar Bone Loss Clinical Trial

Official title:

Bone Regeneration by Means of a Bioactive Glass Scaffold.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105026
• Other study ID #: CBT-109-CT
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2010
• Last updated: April 15, 2010
• Start date: December 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: University of Trieste
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Trieste	Inion Oy