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

NCT02612740 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-11-12

No results posted yet for this study

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

Interventions

BIOLOGICAL

Deproteinized bovine bone

cyst removal followed by heterologous bone grafting

DEVICE

granules of deproteinized bovine bone (Bio-Oss)

Sponsors & Collaborators

  • Geistlich Pharma AG

    collaborator INDUSTRY

  • University of Padova, School of Dental Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-12-31
Completion
2016-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02612740 on ClinicalTrials.gov