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Phase 2 N=22 Randomized Triple-blind Treatment

Bone Material Comparison in Maxillary Sinus Augmentation

Alveolar Bone Resorption · Sequela · Tooth Extrusion

Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements — 14.4; 1.5 percentage of bone height shrinkage

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Shefabone (Biological); Bio-Oss (Biological)
Age
Adult, Older Adult · 20+ yrs
Sex
All
Sponsor
Mohanad Al-Sabbagh
Primary completion
Feb 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements
14.4; 1.5
SECONDARY
Bone Quality
60; 100

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.

Eligibility Criteria

Inclusion Criteria

  • 20 to 75 years of age
  • at least one maxillary edentulous posterior site requiring maxillary sinus grafting and replacement with a dental implant.

Exclusion Criteria

  • current smokers/tobacco users
  • are pregnant
  • have active periodontal disease
  • have uncontrolled diabetes
  • have any autoimmune disease
  • have kidney disease
  • have liver disease
  • are receiving radiation or chemotherapy
  • have any type of radiographic periapical pathology such as a periapical abscess.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04433117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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