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Bone Loss, Alveolar clinical trials

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NCT ID: NCT06204588 Not yet recruiting - Bone Loss, Alveolar Clinical Trials

Evaluation of Regenerative Potential in Horizontal Bone Loss Using VCMX Along With LASER Therapy

Start date: February 2024
Phase: N/A
Study type: Interventional

Background- Periodontitis, an inflammatory disease of the periodontium, is one of the major causes of tooth mortality. Of all the bone destruction patterns that are present in periodontitis, horizontal bone loss is the most common. Therefore, treatment modalities that help in rebuilding horizontal defects are vital in total periodontal reconstruction. Rationale- The supracrestal bone regeneration in cases of horizontal bone loss has remained a mirage with very little recorded success. Volume stable collagen matrix(VCMX), is a porous, cross-linked collagen matrix of porcine origin designed to facilitate cell and vascular ingrowth and soft-tissue volume augmentation, may be beneficial in maintaining the supracrestal space and may overcome the limitation of bone regeneration in horizontal defects. Evidence has shown that Low level laser therapy(LLLT) based on principal of biostimulation of osteoclastic cells, can have a positive effect on the regeneration of supracrestal bone in horizontal bone destruction. So, this study will be first of its kind using combination of VCMX with LLLT to assess regenerative outcome in treatment of horizontal bone destruction in patients with periodontitis. Objectives: To assess clinical and radiographic regenerative outcome of periodontal tissues using LLLT and placing VCMX with single flap approach(SFA) in treatment of horizontal bone loss as compared to LLLT and SFA. Method: A total of 60 patients will be randomly divided into three groups: Test Group 1: VCMX +LLLT +SFA, Test Group 2:LLLT+SFA, and Control group: SFA. Periodontal parameters will be evaluated at baseline, 3, 6, and 9 months. CBCT will be evaluated at baseline and 9 months. Expected outcome: VCMX with Laser could achieve supracrestal bone regeneration in horizontal bone loss.

NCT ID: NCT04998058 Not yet recruiting - Alveolar Bone Loss Clinical Trials

Autogenous Mesenchymal Stem Cell Culture-Derived Signalling Molecules as Enhancers of Bone Formation in Bone Grafting

Start date: December 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

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 (BoneCeramicā„¢ 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-Gideā„¢). 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.