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

This study has been completed.
Sponsor:
Collaborator:
Inion OY Tampere Finland
Information provided by:
University of Trieste
ClinicalTrials.gov Identifier:
NCT01105026
First received: April 15, 2010
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention Phase
Alveolar Bone Loss
Device: Alveolar Bone Defect Regeneration Following Tooth Extraction
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bone Regeneration by Means of a Bioactive Glass Scaffold.

Resource links provided by NLM:


Further study details as provided by University of Trieste:

Enrollment: 14
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by University of Trieste

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Clozza Emanuele, Division of Dental Sciences and Biomaterials, Department pf Biomedicine, University of Trieste, Trieste, Italy
ClinicalTrials.gov Identifier: NCT01105026     History of Changes
Other Study ID Numbers: CBT-109-CT
Study First Received: April 15, 2010
Last Updated: April 15, 2010
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on August 01, 2014