Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Cysts

Pathological Conditions, Anatomical

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

No filling material was used in the bone healing

cyst removal followed by heterologous bone grafting

Deproteinized bovine bone

granules of deproteinized bovine bone (Bio-Oss)

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.

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.

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

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.

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)

Geistlich Pharma AG

University of Padova, School of Dental Medicine

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Nervous System Diseases

Musculoskeletal Diseases

Eye Diseases

Mouth and Tooth Diseases

Congenital Abnormalities

Fractures, Bone

Facies

Orbital Fractures

Orbital Neoplasms

Zygomatic Fractures

Maxillary Neoplasms

Maxillofacial Injuries

Facial Injuries

Craniocerebral Trauma

Trauma, Nervous System

Skull Fractures

Jaw Neoplasms

Skull Neoplasms

Bone Neoplasms

Bone Diseases

Jaw Diseases

Maxillary Diseases

Stomatognathic Diseases

Eye Neoplasms

Orbital Diseases

(reconstruction with patient specific titanium implant)

(reconstruction with preformed titanium plate preoperatively bended on stereolithographic model)

orbital defects reconstruction will be virtually planned by software and a patient specific titanium implant will be manufactured using milling technique depending on CAD-CAM technology

orbital bone reconstruction with patient specific titanium implant

orbital defects reconstruction will be virtually planned by software and a reconstructed stereolithographic model will be 3D printed and used for preoperatively bending of preformed titanium implant.

orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model

Hatem A Abo El Hassan El Shazly, MMed

Sohag F Medicine

Kamal A Hassanein, Professor

Tarek A Ftohy, Ass. prof

Islam AA Amer, Ass. prof

Reconstruction of orbital defects resulting after trauma; tumor resection; maxillary cyst; craniofacial anomalies and sequestrated bone.... etc., has been a challenging issue over the years and this owing to the complicated anatomy of orbit. Inaccurate orbital reconstruction may lead to devastating cosmetic and functional complications. Titanium mesh for orbital reconstruction has now become "probably" the most popular material for orbital wall reconstruction worldwide. Innovation of CAD-CAM technology and its application in maxillofacial surgery will markedly improve the surgical outcome. This study will assess the accuracy of orbital reconstruction using CAD-CAM technology and to compare two different modalities for orbital reconstruction based on this technology.

This study will be a prospective cohort study. It will include patients treated with the custom-made implants for orbital blow out fractures, ZMC fractures or tumors. The sample will consist of 34 patients who will need orbital reconstruction and will be operated in Maxillofacial, Head and Neck Unit, General Surgery Department, Faculty Of Medicine, Sohag University, Egypt. The patients will be randomly divided into two groups, group (A) reconstructed with patient specific implant and group (B) reconstructed with preformed plate preoperatively bended on stereolithographic model. The reconstructive outcomes are assessed by clinical and ophthalmological examinations and accuracy analysis by comparing the preoperative and postoperative multi slice computed tomography data. All patients will be assessed clinically, ophthalmologically, and radiographically using computed tomography (CT) then virtual surgical planning and custom-made patient implant will be manufactured. Post-operative clinical evaluation will be done, and radiographic evaluation of all patients will be done by CT scan within one week and 6 months after the procedure. comparing data of the two groups will be done using appropriate methods.

the participants are assigned to two groups randomly A and B and receive two different intervention modality throughout the study and the results will be compared between the two groups

Application of CAD-CAM Technology in Orbital Bone Reconstruction

Comparison of Two Different Modalities for Orbital Reconstruction Based on CAD-CAM Technology: A Clinical Randomized Trial

assessment of motility of eye globe using extraocular muscle function test

cost of the patient specific implant and the cost of the stereolithographic model and preformed titanium implant

implant displacement, bleeding, infection, pain

assessment of the patients satisfaction to the results post operative using scoring system from 1 to 5 in which :

* 1 = Excellent
* 2 = good
* 3 = Fair
* 4 = not bad
* 5 = poor

testing of visual acuity of the affected eye pre and post operative

assessment of changes in cosmetic results following surgery by one of the supervisors using a scoring system from 1 to 4 in which:

* 1 = Excellent
* 2 = good
* 3 = Fair
* 4 = poor

pre and post operative reconstructed orbit volume will be measured using multi slice computed tomography (MSCT) image loaded on software and compared with preoperative and with healthy non affected orbit

pre and post operative measurement of globe position within the bony orbit using MSCT image loaded on software and comparing measures with preoperative and with healthy non affected orbit

in patients with associated ZMC affection, symmetry with the healthy side and prominence of the zygomatic eminence will be measured using MSCT image loaded on software and compared with preoperative and with healthy non affected ZMC

Hatem Adel Aboelhassan

specialist of maxillofacial, head and neck surgery

Rare Diseases

Bone Cysts

Oculocerebral Syndrome With Hypopigmentation

MSV treatment: Mesenchymal stem cells from bone marrow expanded by GMP-compliant procedure in IBGM cell production unit in autologous plasma scaffold and implanted in maxillary bone cavities after cyst removal

Autologous maxillary bone marrow mesenchymal stem cells (MSV-H) collected from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV)

MSV treatment

Luis M Redondo, MD, PhD

Ana Sánchez, MD, PhD

Javier García-Sancho, MD, PhD

Jose Becerra, PhD

This trial pretends to validate for clinical use a bioengineered product composed of MSV cells (mesenchymal stem cells produced by IBGM, Valladolid, which have already been approved by the Spanish Regulatory Agency for three previous clinical trials) and a cross-linked matrix of autologous plasma patented by The Blood and Tissue Bank of Asturias (WO2008/ 119855) for bone maxillary cysts refilling. These two groups collaborate in the present project with the team of Maxillofacial Surgery of the Hospital Universitario del Río Hortega, who leads the clinical trial and deals with the medical aspects. The proposed trial is based on positive results obtained in previous animal studies performed by the present multidisciplinary team. The investigators propose a phase I / II clinical trial with 10 patients suffering from bone cysts in the maxillofacial region. Autologous mesenchymal stem cells isolated from a bone marrow sample will be seeded in the autologous plasma matrix and cultivated for 3 weeks. At this time, the cyst will be removed by surgery and the cavity filled with the protein matrix containing the mesenchymal cells. Checks will be conducted at 3 weeks, 3 and 6 months following the evolution of the cavity by panoramic radiography and computerized tomography scan.

The objective of this project is to provide a competitive clinical solution with an autologous product, a balanced cost and the possibility of extending use to other pathologies.

This protocol includes treatment of 10 patients with cystic disease of the jaws that meet all the inclusion criteria and none of the exclusion criteria.

For autologous cell preparation a sample of spongy bone from the maxillary tuberosity and 20 ml of serum are obtained from the patient in order to prepare the crosslinked protein matrix and the MSV-H cells. Cells are selected and expanded under GMP conditions according to the methodology used in previous trials (EudraCT 2005-005498-36, 2008-001191-68 and 2009-0170450-11 ). MSV-H cells are obtained directly from biopsy culture jawbone of the patient by cultivation techniques "in vitro" and differentiate for 21 days once conveyed in the matrix with osteogenic differentiation medium of the following composition: DMEM, 10% FBS, 1% P / E, 0.1 mM dexamethasone, 50 mM ascorbate 2-phosphate, 10 mM phosphate ßGlicerol. All differentiation factors have already been approved for clinical use. After the period of the product differentiation can be implanted to the patient.

The bioimplant is used to refill the bone defects after osteotomy and maxillary cyst enucleation, with 5-10 million cells per unit of 2 cm in diameter and 0.3 cm thick. The cavity is closed with the mucoperiosteal flap and sutured with reabsorbable material. The end point of the trial is to evaluate the feasibility, safety and indications of treatment efficacy according to both clinical criteria and objective imaging confirming the volumetric bone regeneration and maintenance over time. For this purposes orthopantomography exploration will be performed before and 2 and 6 months after intervention.

MSV-H autologous transplantation: Mesenchymal stem cells from bone marrow expanded by GMP-compliant procedure in IBGM cell production unit in autologous plasma scaffold and implanted in maxillary bone cavities after cyst removal

Treatment Of Maxillary Bone Cysts With Autologous Bone Mesenchymal Stem Cells (MSV-H)

Regeneration of Maxillary Bone Cystic Cavities by Bio Implant of MSHV-H Cells Associated to a Cross-linked Serum Scaffold

Clinical review and orthopantomograpy at different periods (0, 2 weeks, 2 months and 6 months) assessing evolution from baseline and possible complications.

Imaging exploration to evaluate effectiveness through development of criteria for orthopantomography and bone-CT quantitative bone regeneration Evolution at 2 and 6 months from intervention will be assessed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Deproteinized Bovine Bone in Alveolar Bone Critical Size Defect (>2cm) Secondary to Cyst Removal	NCT02612740	Maxillary Cyst	Deproteinized b... granules of dep...	18 Years - 70 Years	University of Padova, School of Dental Medicine
Application of CAD-CAM Technology in Orbital Bone Reconstruction	NCT05438784	Orbital Bone Fr... Maxillary Cyst Maxillary Neopl... Zygomatic Fract... Orbital Neoplas... Facial Deformit...	orbital bone re... orbital bone re...	16 Years -	Sohag University
Application of CAD-CAM Technology in Orbital Bone Reconstruction	NCT05438784	Orbital Bone Fr... Maxillary Cyst Maxillary Neopl... Zygomatic Fract... Orbital Neoplas... Facial Deformit...	orbital bone re... orbital bone re...	16 Years -	Sohag University
Deproteinized Bovine Bone in Alveolar Bone Critical Size Defect (>2cm) Secondary to Cyst Removal	NCT02612740	Maxillary Cyst	Deproteinized b... granules of dep...	18 Years - 70 Years	University of Padova, School of Dental Medicine
Treatment Of Maxillary Bone Cysts With Autologous Bone Mesenchymal Stem Cells (MSV-H)	NCT01389661	Maxillary Cyst Bone Loss of Su...	MSV treatment	18 Years - 65 Years	Red de Terapia Celular

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