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

Primary Purpose

Alveolar Bone Loss

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Alveolar Bone Defect Regeneration Following Tooth Extraction
Sponsored by
University of Trieste
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring alveolar ridge preservation, bioactive glass, tooth extraction, graft material

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    bioactive glass

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 15, 2010
    Last Updated
    April 15, 2010
    Sponsor
    University of Trieste
    Collaborators
    Inion Oy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01105026
    Brief Title
    A Clinical Investigation to Evaluate the Healing of Tooth Extraction Sites Filled With BioRestore™
    Official Title
    Bone Regeneration by Means of a Bioactive Glass Scaffold.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Trieste
    Collaborators
    Inion Oy

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alveolar Bone Loss
    Keywords
    alveolar ridge preservation, bioactive glass, tooth extraction, graft material

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    bioactive glass
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Alveolar Bone Defect Regeneration Following Tooth Extraction
    Intervention Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22848877
    Citation
    Clozza E, Biasotto M, Cavalli F, Moimas L, Di Lenarda R. Three-dimensional evaluation of bone changes following ridge preservation procedures. Int J Oral Maxillofac Implants. 2012 Jul-Aug;27(4):770-5.
    Results Reference
    derived
    PubMed Identifier
    22691124
    Citation
    Clozza E, Pea M, Cavalli F, Moimas L, Di Lenarda R, Biasotto M. Healing of fresh extraction sockets filled with bioactive glass particles: histological findings in humans. Clin Implant Dent Relat Res. 2014 Feb;16(1):145-53. doi: 10.1111/j.1708-8208.2012.00463.x. Epub 2012 Jun 12.
    Results Reference
    derived

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

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