Maxillary Sinus Augmentation With Xenogeneic Bone Graft Associated or Not With Fibrin Rich in Platelets and Leukocytes Produced by Horizontal Centrifugation: A Randomized Clinical Trial.
Condition: Platelet-rich Fibrin; Sinus Floor Augmentation; Cone-beam Computed Tomography; Dental Implants; Bone Substitutes; Maxillary Sinus; Atrophic Maxilla
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      The objective of study is to evaluate the influence of the use of Platelet Rich Fibrin (PRF)
      from the patient's produced by a new horizontal centrifugation protocol associated with
      particulate xenogenous bone graft in the rehabilitation of atrophic maxillary sinus for early
      osseointegrated implants plancement. In a split-mouth model, twelve patients in need of
      rehabilitation with at least two bilateral implants in the regions of atrophic maxillary
      sinus will simultaneously undergo bone reconstruction using deproteinized particulate
      xenogenous bone (Bio-Oss Small®; Geistlich AG, Wolhusen , Switzerland). Randomly, one of the
      surgical sites of each patient will be reconstructed using the associated technique of solid
      PRF + Liquid PRF with the xenogen material, where at the end of the grafting procedure, both
      sites will be protected by a collagen membrane (Bio-Gide® Compressed; Geistlich AG, Wolhusen,
      Switzerland) positioned over the surgical access of the maxillary sinus. During the research,
      cone-beam computed tomography scans will be performed preoperatively, immediately after
      surgical procedure, 3 months after maxillary sinus reconstruction, after immediate implants
      placement and 12 months after functional load of the implants for comparative volume
      measurement of tissue gain and the maintenance of the grafted tissue. During the implant
      surgery, bilateral biopsies will be collected after 4 months of the regenerative surgical
      procedure during the early dental implants surgery by virtually guided surgery. The stability
      of the implants will be measured by means of resonance frequency analysis (ISQ) after the
      immediate postoperative period and 6 postoperative months as the clinical success rates of
      the implants after 12 months with functional load. The tissue samples will be used for
      histological, histomorphometric, immunohistochemistry and microtomographic analysis. All data
      obtained will be statistically analyzed.
    


Intervention name(s): Maxilar Sinus augmentation; Dental implant placement using guided surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): The patients will be submitted to bilateral sinus augmentation using two different techniques to provide enough bone tissue for dental implants placement.; After 4 months of sinus augmentation, patients will be prepared to receive dental implants for oral rehabilitation. Performed by guided surgery the implants will be placed at the best location for the rehabilitation and at the place were the sinus lighting were performed.
Other intervention name(s): Maxilar sinus lift; Maxilary sinus lifting; Dental implant; Dental implant surgery; Dental implant guided surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment