Clinical trial · Interventional

Deproteinized Bovine Bone in Alveolar Bone Critical Size Defect (>2cm) Secondary to Cyst Removal

Deproteinized Bovine Bone for the Treatment of Alveolar Bone Critical Size Defect in Humans: A Randomized Clinical Pilot Study

NCT02612740CI-TRIAL-00048236completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Maxillary Cyst	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Deproteinized bovine bone	Biological	—	UNRESOLVED
granules of deproteinized bovine bone (Bio-Oss)	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Test Group
description
The bone defect was filled with granules of deproteinized bovine bone (Bio-Oss, Geistlich Pharm, AG Wolhausen, Switzerland)
interventionNames
1. Biological: Deproteinized bovine bone
2. Device: granules of deproteinized bovine bone (Bio-Oss)
type
NO_INTERVENTION
label
Control Group
description
No filling material was used in the bone healing

Primary outcomes (1)

measure
Bone volume evaluation
timeFrame
one year
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

* no smoking for at least 6 months;
* preoperative radiological diagnosis of radiolucent lesion of probable cystic origin;
* bone defect \> 2 cm (diameter);
* ASA1;
* consent to the study inclusion.

Exclusion Criteria:

* subjects in need of treatment with a hemostatic material;
* active infection or inflammation in the treatment area;
* uncontrolled diabetes;
* bone diseases ( Paget's disease, patients undergoing bisphosphonate therapy, multiple myeloma, bone metastases);
* previous radiation therapy in the head and neck region;
* patients not able to take part to the follow-up program.

References

Publications (0)

Data not yet available

No reference posted for this study.