Bone Material Comparison in Maxillary Sinus Augmentation

NCT04433117 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 58349
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Bone Resorption; Sequela; Tooth Extrusion

Keywords

Sinus pneumatization; Socket preservation; Sinus augmentation

Outcome Measures

Primary Outcomes (1)

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

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

  5 months

Secondary Outcomes (1)

• Bone Quality

  5.5 months

Study Arms (2)

Control Group

OTHER

Control group in this study will comprise of 10 subjects and will receive Bio-Oss xenograft bone material.

Biological: Bio-Oss

Test Group

EXPERIMENTAL

The test group in this study will comprise of 10 subjects and will receive Shefabone synthetic bone substitute.

Biological: Shefabone

Interventions

Shefabone BIOLOGICAL

Silica-calcium phosphate composite.

Test Group

Bio-Oss BIOLOGICAL

Xenograft Bone substitute. Bone from animals.

Also known as: Bio-Oss by Geistlich

Control Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohanad Al-Sabbagh: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Interventions

Bio-Oss

Results Point of Contact

• Title: Dr. Mohanad Al-Sabbagh
• Organization: University of Kentucky

malsa2@email.uky.edu

859-257-3003

Study Officials

• Mohanad Al-Sabbagh, DDS

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: June 17, 2020
• Primary Completion: February 14, 2023
• Study Completion: March 1, 2023
• Last Updated: March 21, 2024
• Results First Posted: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)