A Clinical Investigation to Evaluate the Healing of Tooth Extraction Sites Filled With BioRestore™
Bone Regeneration by Means of a Bioactive Glass Scaffold.
1 other identifier
interventional
14
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 15, 2010
CompletedFirst Posted
Study publicly available on registry
April 16, 2010
CompletedApril 16, 2010
November 1, 2009
11 months
April 15, 2010
April 15, 2010
Conditions
Keywords
Study Arms (1)
bioactive glass
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Systemically healthy females or males subjects.
- They did not smoke
- Did not take any medications.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Triestelead
- Inion Oycollaborator
Related Publications (2)
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.
PMID: 22848877DERIVEDClozza 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.
PMID: 22691124DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 15, 2010
First Posted
April 16, 2010
Study Start
December 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
April 16, 2010
Record last verified: 2009-11