Alveolar Bone Loss Clinical Trial
Official title:
Autogenous Mesenchymal Stem Cell Culture-Derived Signalling Molecules as Enhancers of Bone Formation in Bone Grafting
This study aims to evaluate bone formation in grafts in terms of its quality (density), quantity (volume) and maturation obtained with the application of a tissue-engineered bone grafting compound containing concentrated autogenous cell-culture medium (CM) and a synthetic bone substitute. The present study was designed as an experimental prospective split-mouth randomized controlled clinical trial. After protocol approval by the Research Ethics Committee, a total of 20 consecutive participants in need of maxillary reconstruction aiming implant-supported oral rehabilitation will be invited to join the study. To collect autogenous adipose tissue-derived mesenchymal stem cells (hASCs), an outpatient lipoplasty procedure at the abdominal area of each patient will be performed. To isolate and expand hASCs from the lipoaspirate, specific cell culture protocols will be followed, resulting in cultured viable cells and their conditioned medium (CM). Cells and CM will be then separated by a sequence of filters and centrifugation, and isolated CM will be frozen. ELISA will analyze the presence of chemokines and their concentration in CM before grafting. Following pre-op surgical planning, both maxillary sinuses of each patient will be grafted internally applying a lateral window to each sinus. The bony floor of the test maxillary sinus will be augmented with synthetic bone substitute (BoneCeramic™ 1-2 mm) mixed with 10 to 15 ml of CM (test). The control site will receive bone substitute with saline. Lateral windows in both sinuses will be then closed with a collagen membrane (Bio-Gide™). After 6 months, first-stage implant surgery will be performed placing 6 implants in each patient. Registration of implant stability by manual torque wrench will be performed. Also, bone biopsies from each drilled implant site will be collected for histology, histomorphometry and immunohistochemistry (RT-PCR). Tomographic evaluation of the bone formation will include cone beam computed tomographies (CBCTs) at pre-operative [Baseline], 90 [T1] and 180 [T2 = implant placement] days for bone 3D image analysis.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | December 30, 2025 |
Est. primary completion date | August 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Years and older |
Eligibility | Inclusion Criteria: - patients >35 years-old. - presenting highly atrophic fully edentulous maxilla (residual bone height <5 mm). - In need of bilateral sinus floor augmentation aiming full mouth implant-supported rehabilitation. - having teeth extraction at least 8 weeks prior to bone augmentation. Exclusion Criteria: - smokers, illicit drug users and alcohol daily consumers. - patients with metabolic and/or systemic diseases leading to impaired healing (e.g. decompensated diabetes, leukocyte or coagulation disorders, immunosuppression). - history of radiotherapy in the head or neck region. - bisphosphonate-based therapy recipients. - intolerant to general/local anesthesia. |
Country | Name | City | State |
---|---|---|---|
Brazil | Pontificia Universidade Católica do Rio Grande do Sul | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidade Católica do Rio Grande do Sul | ITI International Team for Implantology, Switzerland, KU Leuven, Rio Grande do Sul Brain Institute (InsCer) |
Brazil,
Boeckel DG, Sesterheim P, Peres TR, Augustin AH, Wartchow KM, Machado DC, Fritscher GG, Teixeira ER. Adipogenic Mesenchymal Stem Cells and Hyaluronic Acid as a Cellular Compound for Bone Tissue Engineering. J Craniofac Surg. 2019 May/Jun;30(3):777-783. doi: 10.1097/SCS.0000000000005392. — View Citation
Cabreira CL, Fulginiti RL, Sesterheim P, Shinkai RSA, Teixeira ER. Effect of hyaluronic acid on paracrine signaling of osteoblasts from mesenchymal stromal cells: potential impact on bone regeneration. Clin Oral Investig. 2021 Jul;25(7):4571-4578. doi: 10 — View Citation
Teixeira ER, Boeckel D, Fulginiti R L, Shinkai R S A, Machado D. Mesenchymal stem cells and hyaluronic acid for bone grafting. Clinical Oral Implants Research, 2018, (29), 55-55.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assessment of bone substitute resorption rate | Resorption rate of bone substitute particles (test vs.control) compared by histologic analysis and histomorphometric analyses. | 180 days | |
Primary | Assessment of changes in bone density and quantity | Comparative analysis (test vs. control) of the changes in bone density and quantity by cone beam computed tomography (CBCT). | 0 (baseline), 90 and 180 days | |
Primary | Assessment of bone quantity | Histomorphometry analysis expressed in percentage of newly formed bone | 180 days | |
Secondary | Presence of bone formation markers | RT-PCR assessing specific bone formation markers | 180 days |
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