Plenum® Osshp in Maxillary Sinus Elevation Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-07-30

Brief Summary

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The aim of this study is to qualitatively and quantitatively evaluate bone neoformation in maxillary sinus lift surgery filled with Plenum® Oss hp, compared to filling with autogenous bone, and to verify the association of Plenum® Osshp with i-PRF (i-PR - injectable platelet-rich fibrin). For this, forty (40) participants will be recruited, divided into 4 groups, which will have 10 participants each, namely: Group 1: Autogenous bone; Group 2: Plenum® Osshp; Group 3: Plenum® Osshp; + i-PRF and Group 4: Plenum® Osshp; + autogenous bone. To evaluate the primary outcome, volumetric analysis will be performed by obtaining computed tomography scans at 15 days (T1) and 6 months (T2) after graft surgery, with the aid of a volumetric tomography machine for dentofacial images. The values obtained at T2 will be subtracted from those obtained from T1 to obtain the volumetric stability value. After six months of repair, biopsies will be performed using a trephine drill, followed by the installation of implants and healers. Through microcomputed tomography analysis, the parameters of bone volume fraction (BV/TV), total porosity (Po.Tot), trabecular thickness (Tb.Th), number of trabeculae (Tb.N) and separation of trabeculae (Tb.Sp) will be evaluated. Histomorphometric analysis will be performed to obtain the areas of bone neoformation, connective tissue and remaining biomaterial that will be calculated for each area of the sample (cervical, intermediate, and apical) and later summed, obtaining the total representative area of the sample. Through immunohistochemical analysis, specific primary antibodies to Runx2, VEGF, Osteocalcin (OC) and Tartrate-Resistant Acid Phosphatase (TRAP) will be identified. The occurrence of adverse events will be collected through the analysis of pain, infection, and edema. The quantitative results of the histomorphometric, microtomographic, and volumetric stability analysis will be tabulated and submitted to the ANOVA test, and if they present a statistically significant difference, it will be followed by the Tukey test (post hoc). A significance level of p\<0.05 will be adopted for all tests.

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Detailed Description

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Conditions

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Oral Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

For this, forty (40) participants will be recruited for procedure surgery of maxillary sinus elevation and subsequent installation of dental implants after 06 months of postoperative. And then, the participants will divided into 4 groups, which will have 10 participants each, namely: Group 1: Autogenous bone; Group 2: Plenum® Osshp; Group 3: Plenum® Osshp; + i-PRF and Group 4: Plenum® Osshp; + autogenous bone. To evaluate the primary outcome, volumetric analysis will be performed by obtaining computed tomography scans at 15 days (T1) and 6 months (T2) after graft surgery.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: Autogenous bone graft

The maxillary sinus will treated with autogenous bone graft.

Group Type ACTIVE_COMPARATOR

Group 1: Autogenous bone graft

Intervention Type PROCEDURE

The maxillary sinus will be grafted with the autogenous bone graft.

Group 2: Plenum® Osshp

The maxillary sinus will treated with Plenum® Osshp.

Group Type EXPERIMENTAL

Group 2: Plenum® Osshp

Intervention Type PROCEDURE

The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device.

Group 3: Plenum® Osshp; + i-PRF

The maxillary sinus will treated with Plenum® Osshp associated with i-PRF (i-PR - injectable platelet-rich fibrin).

Group Type EXPERIMENTAL

Group 3: Plenum® Osshp; + i-PRF

Intervention Type PROCEDURE

The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with i-PRF.

Group 4: Plenum® Osshp + autogenous bone graft

The maxillary sinus will treated with Plenum® Osshp associated with autogenous bone graft.

Group Type EXPERIMENTAL

Group 4: Plenum® Osshp + autogenous bone graft

Intervention Type PROCEDURE

The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with autogenous bone graft.

Interventions

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Group 1: Autogenous bone graft

The maxillary sinus will be grafted with the autogenous bone graft.

Intervention Type PROCEDURE

Group 2: Plenum® Osshp

The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device.

Intervention Type PROCEDURE

Group 3: Plenum® Osshp; + i-PRF

The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with i-PRF.

Intervention Type PROCEDURE

Group 4: Plenum® Osshp + autogenous bone graft

The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with autogenous bone graft.

Intervention Type PROCEDURE

Other Intervention Names

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Maxillary sinus elevation surgery Maxillary sinus augmentation Maxillary sinus lift Maxillary sinus elevation surgery Maxillary sinus augmentation Maxillary sinus lift Maxillary sinus elevation surgery Maxillary sinus augmentation Maxillary sinus lift Maxillary sinus elevation surgery Maxillary sinus augmentation Maxillary sinus lift

Eligibility Criteria

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Inclusion Criteria

* Patients with alveolar ridge atrophy, with bone remnant less than 5 mm in height, with adequate bone volume in the ramus and/or symphysis region;
* Over 18 years old;
* And that they have signed the informed consent form.

Exclusion Criteria

* Smokers;
* Patients with uncontrolled systemic diseases;
* Patients with blood dyscrasias;
* Patients with sinus pathologies;
* Patients who take or have used medications that interfere with bone turnover;
* Patients irradiated in the head and neck region;
* Pregnant patients;
* Patients with untreated periodontal disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes