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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bone Regeneration by Means of a Bioactive Glass Scaffold.

Conditions
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Alveolar Bone Loss

Intervention / Treatment
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* Device: Alveolar Bone Defect Regeneration Following Tooth Extraction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bioactive glass<br> | Device: Alveolar Bone Defect Regeneration Following Tooth Extraction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alveolar ridge preservation, bioactive glass, tooth extraction, graft material