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Use of the platelet and leukocyte-rich membrane in maxillary sinus lift surgery

Use of L-PRF in maxillary sinus surgery: randomized triple-blind clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-3bjk6c
Enrollment
Unknown
Registered
2020-08-26
Start date
2019-06-08
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone regeneration, Bone Transplantation

Interventions

Test Group: 11 maxillary sinuses will receive deproteinized bovine bone with the addition of L-PRF. Control group: 11 maxillary sinuses will receive only bovine bone deproteinized as biomaterial. The
Procedure/surgery

Sponsors

Universidade de Pernambuco - UPE
Lead Sponsor
Universidade de Pernambuco - UPE
Collaborator

Eligibility

Age
21 Years to No maximum

Inclusion criteria

Inclusion criteria: Volunteer patients from the spontaneous demand of the Brazilian Dental Association of Pernambuco section; Classified according to the American Society of Anesthesiology as group 1; Over 21 years old; Indication of bilateral maxillary sinus surgery for subsequent rehabilitation with dental implants; Agreement to participate in the research after reading the informed consent form.

Exclusion criteria

Exclusion criteria: Presence of systemic disease; Use of any medication that may interfere with bone metabolism; Smokers; History of pre- or post-operative sinusitis; Surgical approaches previous to the maxillary sinus; History of bone regeneration surgery or previous implantation in the region; Tooth loss in the posterior maxilla less than 1 year.

Design outcomes

Primary

MeasureTime frame
To evaluate bone regeneration of grafted areas of the maxillary sinus with deproteinized bovine bone with and without the addition of L-PRF, verified by means of computed tomography and histomorphometric analyzes. The data will be presented in millimeters for bone heights and anatomical aspects, in hounsfield units for bone density and as a percentage for the quantification of vital bone. We will observe the influence of L-PRF by means of statistical analysis of bone quality of the graft 6 months after maxillary sinus surgery.

Secondary

MeasureTime frame
Evaluate the bone density of the grafted areas of the maxillary sinus with deproteinized bovine bone with and without the addition of L-PRF after 6 months using CT scans, using the hounsfield scale, allowing bone classification according to the hounsfield units.;To evaluate the influence of the anatomical aspects of the maxillary sinus in the grafted areas of the maxillary sinus with the deproteinized bovine bone with and without the addition of L-PRF, using clinical and tomographic measures, such as the size of the lateral window and the buccal-lingual distance of the maxillary sinus , expressed in millimeters. A comparison will be made with bone density and percentage of vital bone formed.;Histomorphometrically evaluate the amount of vital bone formed in the graft after 6 months through analysis in a histomorphometry laboratory with a percentage measure.

Countries

Brazil

Contacts

Public ContactMatheus Frazão

Universidade de Pernambuco - UPE

matheuspfrazao@gmail.com+55-87-999379851

Outcome results

None listed

Source: REBEC (via WHO ICTRP)