An interventional study of Maxilar Sinus augmentation and Dental implant placement using guided surgery in Platelet-rich Fibrin, Sinus Floor Augmentation and Cone-beam Computed Tomography, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
828 studies on the registry are indexed under Atrophy; 122 are open to participants now.
This study's enrollment of 13 is below the median of 34 across 603 interventional studies indexed under Atrophy.
Browse Atrophy studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Split-mouth bilateral sinus augmentation of xenogeneic bone graft associated or not with platelet-rich fibrin produced by horizontal centrifugation.
Procedure: Maxilar Sinus augmentation
Procedure: Dental implant placement using guided surgery
Procedure: Dental implant placement using guided surgery
The patients will be submitted to bilateral sinus augmentation using two different techniques to provide enough bone tissue for dental implants placement.
Also known as: Maxilar sinus lift, Maxilary sinus lifting
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.
Also known as: Dental implant, Dental implant surgery, Dental implant guided surgery
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.
Time frame: 4 Months
Dental Implants ISQ measurement
ISQ will be measured at the moment of implant placement and after 6 months.
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Sao Paulo