Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2021
INTERVENTION: • Tomography (20 participants, 60 total scans): All participants must undergo a cone beam computed tomography (CBCT) exam. The exams will be requested prior to installation of bone grafts (T1), removal of stitches after installation of bone grafts (T2) and before installation of implants (T3). The tomographies will be carried out in a private clinic, using a cone beam tomograph from Morita, model X800, with the following parameters: 95kV; 8mA; 0.125mm Voxel and 18s Full Spin. • Preparation and installation of autogenous graft (control group, 20 participants, split‐mouth study): The 20 recruited participants will initially receive extra and intraoral asepsis with 2% and 0.12% chlorhexidine gluconate, respectively. Afterwards, local anesthesia will be performed with anterior superior alveolar, middle superior alveolar and nasopalatine nerve block (Articaine 4% 1:100,000 ‐Nova DFL, Brazil). A linear incision will be made over the alveolar crest, followed by two vertical incisions and detachment of the muco‐periosteal flap. Once the exposure of the recipient bed is finished, the technique for obtaining the graft in an autogenous block will be started. Anesthesia of the posterior region of the mandible with blockade of the inferior alveolar, buccal and lingual nerves will be performed. Afterwards, a linear incision will be made, followed by detachment of the muco‐periosteal flap and exposure of the ramus of the mandible. The osteotomy will then be performed using frusto‐conical drills and discs mounted in a straight piece. Subsequently, with the aid of a chisel, the bone graft will be removed and the operator will start the procedures for adapting the autogenous graft to the recipient bed, using cutters mounted in a straight piece. Afterwards, the graft will E02.095.147.725.052 J01.637.051.130.325 CONDITION: Alveolar ridge atrofy without teeth PRIMARY OUTCOME: Evaluate the gain in the increase/maintenance of the volume of the bone graft area and the quality of the newly formed bone tissue, by comparing tomographies performed after graft installation (T2) and after 8 months of repair (T3). The volume maintenance increase will be defined by calculating the difference in the area of T3‐T2 in millimeters. INCLUSION CRITERIA: Bone insufficiency in the anterior region, with a minimum height of 7mm and width less than or equal to 5mm evaluated by cone beam computed tomography; Over 18 years old; who have signed the informed consent form. SECONDARY OUTCOME: Assess whether there is a difference in the operative time to perform the ceramic bone graft compared to the autogenous graft. Surgery time will be measured in minutes. Check whether the bone graft (customized or autogenous in block) can interfere with the primary and secondary stability of the implants installed in the region. Primary and secondary stability will be measured using Osstell® Resonance Frequency Analysis (RFA) (Osstell AB, Göteborg, Sweden). Primary Stability: Right after implant placement (8 months after graft placement). Secondary stability: 6 months after implant placement (14 months after graft placement). Values will be obtained in torque (Ncm‐1). Evaluate bone neoformation in the anterior region of the maxilla by evaluating the percentage of newly formed bone tissue, percentage of soft tissue and percentage of residual material from the bone graft. The biopsy will be obtained 8 months after the installation of the bone grafts. Evaluate the adaptation of the personalized bone graft to the recipient bed. Correct fit of the graft will be recorded as yes and the need for fitting will be recorded as no. This variable will be obtained at the time of graft installation. Evaluate the differentiation activity of osteoblastic cells by quantifying the morphogenetic protein ‐2 (BMP‐2). The indirect immunoperoxidase technique with amplifier will be used to prepare the histological slide for binding with the bone metabolism marker antibody Bone Morphogenetic Protein 2 (BMP‐2), 8 months after the installation of the bone grafts. The evaluation will be done by quantifying the expression of BMP‐2, measured by the number of colored nucleus. Evaluate the differentiation of endothelial cells through the quantification of vascular endothelial growth factor (VEGF). The indirect immunoperoxidase technique with amplifier will be used to prepare the histological slide for binding with the vascular endothelial growth factor (VEGF) marker antibody, 8 months after the installation of the bone grafts. The evaluation will be done by quantifying the expression of VEGF, measured by the number of colored nucleus. Evaluate the maturation of the newly formed bone tissue through the quantification of osteocalcin (OCN). The indirect immunoperoxidase technique with amplifier will be used to prepare the histological slide for binding with the bone metabolism marker antibody osteocalcin. This test will be carried out 8 months after the installation of bone grafts. The evaluation will be done by quantifying the expression of OCN, measured by the number of colored nucleus. Evaluate the production of collagen matrix through the quantification of alkaline phosphatase. The indirect immunoperoxidase technique with amplifier will be used to prepare the histological slide for binding with the bone metabolism marker antibody alkaline phosphatase, 8 months after the installation of the bone grafts. The evaluation will be done by quantifying the expression of alkaline phosphatase, measured by the number of colored nucleus. Evaluate the volume of mineralized bone tissue mineralized through micro‐tomographic exams. Obtaining the volume of mineralized tissue, as a percentage, will be performed 8 months after the installation of bone grafts.
Epistemonikos ID: cf694a4a34d186684197700205cf7e00c13bc192
First added on: Aug 25, 2024