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OpenTrials
Completed

NCT Number: NCT04433117

Bone Material Comparison in Maxillary Sinus Augmentation

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

  • 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).
  • With the use of pre-operative and post-operative limited view CBCT (cone-beam computed tomography) radiography, the maxillary sinus bone density will be assessed and compared between the individuals receiving Shefabone and the individuals receiving xenograft material.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shefabone

Biological

Silica-calcium phosphate composite.

Bio-Oss

Biological

Xenograft Bone substitute. Bone from animals.

Other names: Bio-Oss by Geistlich

Primary outcomes

  1. Bone Density - Limited View CBCT (Cone-beam Computed Tomography) Measurements

    Time frame: 5 months

    Bone density will be measured by limited view CBCT radiography pre- and post-operatively.

Secondary outcomes

  1. Bone Quality

    Time frame: 5.5 months

    Bone quality will be measured using histomorphometric analysis.

Sponsors and collaborators

Lead sponsor

Mohanad Al-Sabbagh

Other

Registry information

Official study title

Bone Quality and Quantity in the Maxillary Sinus Grafted With Xenograft or Synthetic Bone Substitute: A Radiographic and Histomorphometric Randomized Controlled Clinical Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2020
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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