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.

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.

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.

Study Overview

• Status: Completed
• Conditions: Dental Implants; Sinus Floor Augmentation; Platelet-rich Fibrin; Maxillary Sinus; Cone-beam Computed Tomography; Bone Substitutes; Atrophic Maxilla
• Intervention / Treatment: Procedure: Maxilar Sinus augmentation; Procedure: Dental implant placement using guided surgery

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14040-904
      • School of Dentistry of Ribeirão Preto - USP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bilateral Sinus Augmentation; Split-mouth bilateral sinus augmentation of xenogeneic bone graft associated or not with platelet-rich fibrin produced by horizontal centrifugation.	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.; Other Names: Maxilar sinus lift; Maxilary sinus lifting
Active Comparator: Early dental implant placement by Guided Surgery	Procedure: 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.; Other Names: Dental implant; Dental implant surgery; Dental implant guided surgery
Active Comparator: Dental implants reopening surgery for implant load	Procedure: 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.; Other Names: Dental implant; Dental implant surgery; Dental implant guided surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Implants ISQ measurement	ISQ will be measured at the moment of implant placement and after 6 months.	6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Chair: Dr. Michel R Messora, Phd, Universidade de São Paulo - FORP-USP; Principal Investigator: Gabriel GD Reis, Phd Student, Universidade de São Paulo - FOR-USP

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: July 15, 2023
• First Submitted That Met QC Criteria: July 15, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 29428820.3.0000.5419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No