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.

Dental Implants Clinical Trial

Official title:

Maxillary Sinus Augmentation With Xenogeneic Bone Graft Associated or Not With Fibrin Rich in Platelets and Leukocytes Produced by Horizontal Centrifugation for Early Implant Placement: a Randomized Controlled Split-mouth Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05957705
• Other study ID #: 29428820.3.0000.5419
• Status: Completed
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: July 15, 2023

Study information

• Verified date: July 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 15, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• need of at least one dental implant in atrophic maxillary sinus region;
• insufficient amount of vertical bone remnant for the dental implants surgery (maximum of 4mm);
• sufficient horizontal bone thickness for dental implants rehabilitation;
• present edentulism in the area to be treated for at least 6 months;
• similar pattern of pneumatization of the maxillary sinuses.

Exclusion Criteria:

• any contraindication for the installation of dental implants;
• need of horizontal bone augmentation;
• pacientes with inflammatory or autoimmune disease in the oral cavity;
• use of immunosuppressants, corticosteroids or bisphosphonates for medical needs;
• pacientes with history of malignancy in the last 5 years;
• smoking patients or patients reporting excessive alcohol consumption;
• decompensated systemic condition, uncontrolled periodontal disease, insulin-dependent diabetic patients, patients with blood-related diseases and patients who need oral rehabilitation in the lower arch;
• It is also noteworthy that patients with a history of reconstructive bone therapies in the maxillary sinus region or with a history of oroantral communication will be excluded from this research.

Related Conditions & MeSH terms

• Atrophic Maxilla
• Atrophy
• Bone Substitutes
• Cone-beam Computed Tomography
• Dental Implants
• Maxillary Sinus
• Platelet-rich Fibrin
• Sinus Floor Augmentation

Intervention

Procedure:
• Maxilar Sinus augmentation
The patients will be submitted to bilateral sinus augmentation using two different techniques to provide enough bone tissue for dental implants placement.
• Dental implant placement using guided surgery
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.

Locations

Country	Name	City	State
Brazil	School of Dentistry of Ribeirão Preto - USP	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Micro-CT and Histometric analyses	After the period of 4 months from sinus reconstructions, during the dental implant placement by guided surgery, bone samples will be collected at the same location of the implants preparation. The collected bone tissue will be prepared and submitted to Micro-CT and histometric analyses.	4 Months
Secondary	Dental Implants ISQ measurement	ISQ will be measured at the moment of implant placement and after 6 months.	6 months