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

Sponsor

University of Padova, School of Dental Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02612740

Collaborator

Geistlich Pharma AG (Industry)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Maxillary Cyst	Biological: Deproteinized bovine bone Device: granules of deproteinized bovine bone (Bio-Oss)	Phase 2

Detailed Description

The healing of extensive alveolar bone defects secondary to cyst removal is not predictable. Residual voids of various entity may persist. Some Authors proposed the use of grafting materials to reconstitute the loss of hard tissue. The primary objective was to determine the efficacy of bone grafting.The secondary objectives were to evaluate the incidence rate of wound dehiscence, pus drainage, recurrence and other complications 7 and 30 days and 6 months after surgery. Recurrence at 12 months of healing was also evaluated. For all patients included, surgeries were performed in conscious sedation and local anesthesia.Full-thickness flap of the appropriate shape and dimensions were lifted, and the bone exposed. When necessary, osteotomy was done, in order to enucleate the cystic lesion. The residual bone cavity was filled with deproteinized bovine bone (test), or not filled with any graft material (control). The flap was finally repositioned and sutured in order to achieve primary closure.

In both test and control groups antibiotic therapy with amoxicillin tablets of 1 g every 12 hours for six days (alternatively, for allergic patients, clarithromycin 500 mg tablets twice daily were given) and proper analgesics were prescribed. Postoperatory physical, therapy was prescribed as well.

Radiological follow up consisted of an orthopantomography and a CT scan taken at 12 months after surgery.For 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). 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 (GL and SR) 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Group The bone defect was filled with granules of deproteinized bovine bone (Bio-Oss, Geistlich Pharm, AG Wolhausen, Switzerland)	Biological: Deproteinized bovine bone cyst removal followed by heterologous bone grafting Device: granules of deproteinized bovine bone (Bio-Oss)
No Intervention: Control Group No filling material was used in the bone healing

Arm

Intervention/Treatment

Experimental: Test Group

The bone defect was filled with granules of deproteinized bovine bone (Bio-Oss, Geistlich Pharm, AG Wolhausen, Switzerland)

Biological: Deproteinized bovine bone

cyst removal followed by heterologous bone grafting

Device: granules of deproteinized bovine bone (Bio-Oss)

No Intervention: Control Group

No filling material was used in the bone healing

Outcome Measures

Primary Outcome Measures

Bone volume evaluation [one year]
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.

Secondary Outcome Measures

physiological parameter (wound dehiscence) [7 days, 1, 6 and 12 months after surgery]
clinical evaluation (present/absent)
physiological parameter (pus drainage) [7 days, 1, 6 and 12 months after surgery]
clinical evaluation (present/absent)
physiological parameter (recurrence) [7 days, 1, 6 and 12 months after surgery]
clinical evaluation (present/absent)
physiological parameter (any other clinical complications) [7 days, 1, 6 and 12 months after surgery]
clinical evaluation (present/absent)
bone density (scale - Hounsfield units) [12 months after surgery]
Bone density analysis was conducted on three tomographic axial images (middle, caudal, cranial) of the healed cystic volume, per each patient of both groups. Bone density in Hounsfield Unit (HU) was obtained with the RadiAnt DICOM Viewer software (RadiAnt DICOM Viewer, version 1.1.8; Meixant, Poznan, Poland)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.