Platelet-rich FibrinNCT05957705

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.

A study testing Maxilar Sinus augmentation and Dental implant placement using guided surgery in people with Platelet-rich Fibrin and Sinus Floor Augmentation, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 75 years
Conditions the study is for: Platelet-rich Fibrin, Sinus Floor Augmentation, Cone-beam Computed Tomography
What is being tested?: Maxilar Sinus augmentation and Dental implant placement using guided surgery
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteBrazil
Study dates: 17 Mar 2021to 15 Jul 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

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

Other trials in Brazil

About this study

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.

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.

Conditions: Platelet-rich Fibrin, Sinus Floor Augmentation, Cone-beam Computed Tomography, Dental Implants, Bone Substitutes, Maxillary Sinus
Being tested: Maxilar Sinus augmentation, Dental implant placement using guided surgery
Medical subject headings: Atrophic Maxilla

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Maxilar Sinus augmentationProcedure or surgery
Also called Maxilar sinus lift, Maxilary sinus lifting
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 surgeryProcedure or surgery
Also called Dental implant, Dental implant surgery, Dental implant 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.

Study groups in NCT05957705
Study group	Role	What they receive
Bilateral Sinus Augmentation	Active comparator	Split-mouth bilateral sinus augmentation of xenogeneic bone graft associated or not with platelet-rich fibrin produced by horizontal centrifugation. Receives: Procedure: Maxilar Sinus augmentation
Early dental implant placement by Guided Surgery	Active comparator	Not described Receives: Procedure: Dental implant placement using guided surgery
Dental implants reopening surgery for implant load	Active comparator	Not described Receives: Procedure: Dental implant placement using guided surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 Months

Secondary outcomes (1)

Dental Implants ISQ measurement
ISQ will be measured at the moment of implant placement and after 6 months.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 202115 Jul 2023

First posted24 Jul 2023
Study start17 Mar 2021
Primary completion30 Apr 2023
Study completion15 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Platelet-rich FibrinStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05957705
Sponsor's protocol ID: 29428820.3.0000.5419
Status last verified: Jul 2023
First submitted: 15 Jul 2023
Last updated: 24 Jul 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
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Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
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All Platelet-rich Fibrin trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT05957705
Acronym / sponsor ID: 29428820.3.0000.5419
Conditions: Platelet-rich Fibrin, Sinus Floor Augmentation, Cone-beam Computed Tomography, Dental Implants, Bone Substitutes, Maxillary Sinus
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: University of Sao PauloUniversity, hospital or other
Study start: 17 Mar 2021 (actual)
Primary completion: 30 Apr 2023 (actual)
Study completion: 15 Jul 2023 (actual)
First posted: 24 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Bilateral Sinus Augmentation	Active comparator	Procedure: Maxilar Sinus augmentationSplit-mouth bilateral sinus augmentation of xenogeneic bone graft associated or not with platelet-rich fibrin produced by horizontal centrifugation.
Early dental implant placement by Guided Surgery	Active comparator	Procedure: Dental implant placement using guided surgery
Dental implants reopening surgery for implant load	Active comparator	Procedure: Dental implant placement using guided surgery

Who may qualify

Ages: 35 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Maxilar Sinus augmentationAlso: Maxilar sinus lift, Maxilary sinus liftingThe patients will be submitted to bilateral sinus augmentation using two different techniques to provide enough bone tissue for dental implants placement.	Procedure or surgery	Bilateral Sinus Augmentation
Dental implant placement using guided surgeryAlso: Dental implant, Dental implant surgery, Dental implant guided surgeryAfter 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.	Procedure or surgery	Dental implants reopening surgery for implant load, Early dental implant placement by Guided Surgery

Primary outcome

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.

1 secondary outcome

Dental Implants ISQ measurement
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
Individual participant dataSharing planned: Undecided

Related trials for Platelet-rich Fibrin

Not yet recruiting
Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw
Osteonecrosis of the Jaw
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
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Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. Michel R Messora, Phd study chair

Universidade de São Paulo - FORP-USP

Gabriel GD Reis, Phd Student principal investigator

Universidade de São Paulo - FOR-USP

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Micro-CT and Histometric analyses (time frame: 4 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05957705.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.