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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01105026
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : April 16, 2010
Inion Oy
Information provided by:
University of Trieste

Brief 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.

Condition or disease Intervention/treatment Phase
Alveolar Bone Loss Device: Alveolar Bone Defect Regeneration Following Tooth Extraction Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Clozza Emanuele, Division of Dental Sciences and Biomaterials, Department pf Biomedicine, University of Trieste, Trieste, Italy Identifier: NCT01105026     History of Changes
Other Study ID Numbers: CBT-109-CT
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: April 16, 2010
Last Verified: November 2009

Keywords provided by University of Trieste:
alveolar ridge preservation, bioactive glass, tooth extraction, graft material

Additional relevant MeSH terms:
Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases