Sponsor study identifier
interventional
20
0 countries
N/A
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
October 2016
Actual (reported)The aim of this study was to evaluate the effect of the use of deproteinized bovine bone as a filler material of critical-sized (diameter \>=20 mm) bony defects derived from the excision of maxillary and mandibular cysts. 20 patients were considered. Patients were randomly divided into 2 groups according to the type of treatment: the bone defect was filled with granules of deproteinized bovine bone (test); no filling material (control). Clinical parameters were recorded at 7 days, 1, 6 and 12 months after surgery. Radiological follow up consisted of an orthopantomograph and a CT scan taken at the baseline (pre-operatory) and 12 months after surgery. In order to evaluate the difference in percentage of filling of the bone defect between the two groups, the pre-op and the 1-year radiolucent volumes were evaluated in the CT scans.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
December 2014
Actual (reported)September 21, 2015
Actual (reported)November 24, 2015
Actual (reported)October 2016
Actual (reported)Bone volume evaluation
A computerized method was adopted to compare the pre-operatory and the 12 months post-operatory CT scan. The Digital Imaging and Communication in Medicine (DICOM) obtained files were transferred to a Mac Pro Quad 2.66- GHz work- station (Apple Corp., Cupertino, CA, USA) and analyzed using an open-source medical image processing software (OsiriX v. 5.8.5, Pixmeo Sarl, Bernex, Switzerland) (Lizio et al, 2013; Bittermann et al, 2014). The margin of the radiolucent areas of each CT slice was traced manually on each axial view, and the volume calculated by the software with the ROI (Region Of Interest) tool. Volumes in mm3 and 3D images were obtained for each pre-op and post-op ct scan, for every test and control patient. Each exam was evaluated by two assessors who were trained in radiological diagnosis and measurement detection. The volumetric reduction of the cysts was calculated by subtracting the preoperatory from the post operatory volumes, both in test and control groups.
one year
physiological parameter (wound dehiscence)
7 days, 1, 6 and 12 months after surgery
physiological parameter (pus drainage)
7 days, 1, 6 and 12 months after surgery
physiological parameter (recurrence)
7 days, 1, 6 and 12 months after surgery
physiological parameter (any other clinical complications)
7 days, 1, 6 and 12 months after surgery
bone density (scale - Hounsfield units)
12 months after surgery
The bone defect was filled with granules of deproteinized bovine bone (Bio-Oss, Geistlich Pharm, AG Wolhausen, Switzerland)
No filling material was used in the bone healing
cyst removal followed by heterologous bone grafting
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
20 participants (actual enrollment reported by the registry).
First Submitted
September 21, 2015
First Posted
November 24, 2015
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
October 2016
Actual (reported)Last Updated
November 12, 2020
Record last verified: 2020-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: