Bone Material Comparison in Maxillary Sinus Augmentation
Condition: Alveolar Bone Resorption; Sequela; Tooth Extrusion
MeSH terms: Bone Resorption
Study type: Interventional
Phase: Phase 2

Summary: 
      Hard and soft tissue deficiencies of an alveolar ridge arise as sequelae of tooth extraction
      when socket preservation is not applied. In addition, extraction of posterior maxillary teeth
      causes pneumatization of the maxillary sinus in relation to other fixed landmarks such as the
      teeth. These anatomic sinus limitations and alveolar bone deficiencies are the main
      challenges for dental implant placement. Different bone substitutes have been used to augment
      bone in pneumatized maxillary sinuses.

      Scaffolding materials such as xenografts or synthetics substitutes have been proven to be a
      viable alternative.

      Xenografts are obtained from nonhuman species and serve as a scaffold for the formation of
      new bone (osteoconduction). Histologic evaluation of maxillary sinuses grafted with
      xenografts revealed newly formed bone to be mostly woven bone with some remodeling to
      lamellar bone. These histologic findings reaffirm the osteoconductive ability of xenografts
      when used as the sole grafting material in maxillary sinus augmentation. Xenografts appear to
      be an effective method for maxillary sinus grafting and demonstrate limited resorption over
      time. Sinuses augmented with synthetic bone substitute (SBS) also appear to successfully
      integrate based on recent histomorphometric studies. Vascularization and trabecular bone
      formation in sinuses grafted with SBS has been previously demonstrated. One type of SBS
      includes porous granules of bioactive and resorbable silica-calcium phosphate nanocomposite
      (ShefaBone). ShefaBone grafts offer a novel alternative that can potentially unite the 3
      salient bone-forming properties (osteoinduction, osteoconduction, and osteogenesis).
      ShefaBone has unique properties including: 1) bioactivity 2) bioresorbablility, and 3)
      allowing for the uptake of calcium ions from the physiological solution and releasing
      phosphate and silicate ions which aid in bone formation. A material with such properties will
      substitute bone in a more controlled and effective combination that can be obtained in many
      clinical situations, without the disadvantages found with autograft. ShefaBone has
      demonstrated successful regenerative properties for bony defects. To our knowledge, there is
      no reported clinical studies on the use of SCPC material to graft a pneumatized maxillary
      sinus. This aim of this current study is to compare SCPC to commonly used xenograft material
      in an augmented maxillary sinus.
    

Detailed description: 
      1. To assess the quality and quantity of the maxillary sinus bone prior to the placement of
           dental implants and subsequent restorations, approximately 20 patients will be randomly
           assigned to receive an augmentation of the maxillary sinus region using either Shefabone
           (synthetic bone) or Bio-Oss (xenograft).

        2. With the use of pre-operative and post-operative limited view CBCT radiography, the
           maxillary sinus bone density will be assessed and compared between the individuals
           receiving Shefabone and the individuals receiving xenograft material.

        3. Histomorphometric analysis will be used to assess, compare and contrast the quality and
           the quantity of the new vital bone cells generated when using these different graft
           materials.
    

Intervention name(s): Shefabone; Bio-Oss
Intervention type(s): Biological; Biological
Intervention description(s): Silica-calcium phosphate composite.; Xenograft Bone substitute. Bone from animals.
Other intervention name(s): Bio-Oss by Geistlich
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled clinical trial. Entails 2 groups of subjects which will be randomly assigned. Group 1 will be the control group, and group 2 is test group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sinus pneumatization; Socket preservation; Sinus augmentation