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
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
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
NCT ID
NCT01105026
First Posted
April 15, 2010
Last Updated
April 15, 2010
Sponsor
University of Trieste
Collaborators
Inion Oy
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
Learn more about this trial
A Clinical Investigation to Evaluate the Healing of Tooth Extraction Sites Filled With BioRestore™
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