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Completed

NCT Number: NCT05957705

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.

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.

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Key information

Conditions

Platelet-rich Fibrin Atrophic Maxilla Bone Diseases Bone Resorption Bone Substitutes Cone-Beam Computed Tomography Dental Implants Jaw Diseases Maxillary Diseases Maxillary Sinus Musculoskeletal Diseases Sinus Floor Augmentation Stomatognathic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry of Ribeirão Preto - USP

Ribeirão Preto, São Paulo, 14040-904, Brazil

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Maxilar Sinus augmentation

Procedure

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

Dental implant placement using guided surgery

Procedure

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

Primary outcomes

  1. Micro-CT and Histometric analyses

    Time frame: 4 Months

    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.

Secondary outcomes

  1. Dental Implants ISQ measurement

    Time frame: 6 months

    ISQ will be measured at the moment of implant placement and after 6 months.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2023
Registry last updated
Jul 24, 2023

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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