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

NCT02612740 | Completed Phase 2 DMC

• 1 other identifier: 2187P
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Maxillary Cyst

Keywords

Bio Oss; critical-size defect; bone grafting; cyst; CT bone analysis; alveolar bone

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

Test Group

EXPERIMENTAL

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

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

Control Group

NO INTERVENTION

No filling material was used in the bone healing

Interventions

Deproteinized bovine bone BIOLOGICAL

cyst removal followed by heterologous bone grafting

Test Group

granules of deproteinized bovine bone (Bio-Oss) DEVICE

Test Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• no smoking for at least 6 months;
• preoperative radiological diagnosis of radiolucent lesion of probable cystic origin;
• bone defect \> 2 cm (diameter);
• ASA1;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova, School of Dental Medicine: lead
• Geistlich Pharma AG: collaborator

MeSH Terms

Conditions

Cysts

Condition Hierarchy (Ancestors)

Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: November 24, 2015
• Study Start: April 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: October 1, 2016
• Last Updated: November 12, 2020

Record last verified: 2020-11