Maxillary CystPhase 2NCT02612740
Deproteinized Bovine Bone in Alveolar Bone Critical Size Defect (>2cm) Secondary to Cyst Removal
A Phase 2 study testing Deproteinized bovine bone and granules of deproteinized bovine bone (Bio-Oss) in people with Maxillary Cyst, run by University of Padova, School of Dental Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Cyst
- What is being tested?
- Deproteinized bovine bone and granules of deproteinized bovine bone (Bio-Oss)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Deproteinized Bovine Bone for the Treatment of Alveolar Bone Critical Size Defect in Humans: A Randomized Clinical Pilot Study
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.
Read the 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.
- Conditions
- Maxillary Cyst
- Being tested
- Deproteinized bovine bone, granules of deproteinized bovine bone (Bio-Oss)
- Keywords
- Bio Oss, critical-size defect, bone grafting, cyst, CT bone analysis, alveolar bone
- Medical subject headings
- Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deproteinized bovine boneBiological
cyst removal followed by heterologous bone grafting
granules of deproteinized bovine bone (Bio-Oss)Device
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | The bone defect was filled with granules of deproteinized bovine bone (Bio-Oss, Geistlich Pharm, AG Wolhausen, Switzerland) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (5)
physiological parameter (wound dehiscence)
clinical evaluation (present/absent)
Measured: 7 days, 1, 6 and 12 months after surgery
physiological parameter (pus drainage)
clinical evaluation (present/absent)
Measured: 7 days, 1, 6 and 12 months after surgery
physiological parameter (recurrence)
clinical evaluation (present/absent)
Measured: 7 days, 1, 6 and 12 months after surgery
physiological parameter (any other clinical complications)
clinical evaluation (present/absent)
Measured: 7 days, 1, 6 and 12 months after surgery
bone density (scale - Hounsfield units)
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)
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startApr 2010
- Primary completionDec 2014
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova, School of Dental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612740
- Sponsor's protocol ID
- 2187P
- Status last verified
- Nov 2020
- First submitted
- 21 Sep 2015
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deproteinized Bovine Bone for the Treatment of Alveolar Bone Critical Size Defect in Humans: A Randomized Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT02612740
- Acronym / sponsor ID
- 2187P
- Conditions
- Maxillary Cyst
- Keywords
- Bio Oss, critical-size defect, bone grafting, cyst, CT bone analysis, alveolar bone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Padova, School of Dental MedicineUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- Apr 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Biological: Deproteinized bovine bone, Device: granules of deproteinized bovine bone (Bio-Oss)The bone defect was filled with granules of deproteinized bovine bone (Bio-Oss, Geistlich Pharm, AG Wolhausen, Switzerland) |
| Control Group | No intervention | –No filling material was used in the bone healing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deproteinized bovine bonecyst removal followed by heterologous bone grafting | Biological | Test Group |
| granules of deproteinized bovine bone (Bio-Oss) | Device | Test Group |
Primary outcome
Bone volume evaluation
Time frame: 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.
5 secondary outcomes
physiological parameter (wound dehiscence)
Time frame: 7 days, 1, 6 and 12 months after surgery
physiological parameter (pus drainage)
Time frame: 7 days, 1, 6 and 12 months after surgery
physiological parameter (recurrence)
Time frame: 7 days, 1, 6 and 12 months after surgery
physiological parameter (any other clinical complications)
Time frame: 7 days, 1, 6 and 12 months after surgery
bone density (scale - Hounsfield units)
Time frame: 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deproteinized bovine bone and granules of deproteinized bovine bone (Bio-Oss) in people with Maxillary Cyst, run by University of Padova, School of Dental Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone volume evaluation (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.