Plenum® Osshp in Maxillary Sinus Elevation Surgery

NCT06136143 | Unknown

• 1 other identifier: Plenum Oss 001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Surgical Procedures

Keywords

Maxillary Sinus; Synthetic Bone Graft; Autogenous Bone Graft; Platelet Rich Fibrin

Outcome Measures

Primary Outcomes (1)

• Rate of the maintenance of volume in the maxillary sinus region.

  Computed tomography scans were performed and compared after graft surgery (T1) and after 6 months of repair (T2). The maintenance of the volume will be defined by the difference in the area of T2-T1.

  Fifteen days (T1) and six months (T2) from postoperative.

Secondary Outcomes (6)

• Rate of the bone neoformation of the synthetic graft in comparison with the autogenous graft and in association with i-PRF.

  Six months from postoperative.

• Rate of the areas of bone neoformation, connective tissue and remnant synthetic graft.

  Six months from postoperative.

• Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.

  Six months from postoperative.

• Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.

  Six months from postoperative.

• Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.

  Six months from postoperative.

Study Arms (4)

Group 1: Autogenous bone graft

ACTIVE COMPARATOR

The maxillary sinus will treated with autogenous bone graft.

Procedure: Group 1: Autogenous bone graft

Group 2: Plenum® Osshp

EXPERIMENTAL

The maxillary sinus will treated with Plenum® Osshp.

Procedure: Group 2: Plenum® Osshp

Group 3: Plenum® Osshp; + i-PRF

EXPERIMENTAL

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

Procedure: Group 3: Plenum® Osshp; + i-PRF

Group 4: Plenum® Osshp + autogenous bone graft

EXPERIMENTAL

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

Procedure: Group 4: Plenum® Osshp + autogenous bone graft

Interventions

Group 1: Autogenous bone graft PROCEDURE

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

Also known as: Maxillary sinus elevation surgery, Maxillary sinus augmentation, Maxillary sinus lift

Group 1: Autogenous bone graft

Group 2: Plenum® Osshp PROCEDURE

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

Also known as: Maxillary sinus elevation surgery, Maxillary sinus augmentation, Maxillary sinus lift

Group 2: Plenum® Osshp

Group 3: Plenum® Osshp; + i-PRF PROCEDURE

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

Also known as: Maxillary sinus elevation surgery, Maxillary sinus augmentation, Maxillary sinus lift

Group 3: Plenum® Osshp; + i-PRF

Group 4: Plenum® Osshp + autogenous bone graft PROCEDURE

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

Also known as: Maxillary sinus elevation surgery, Maxillary sinus augmentation, Maxillary sinus lift

Group 4: Plenum® Osshp + autogenous bone graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M3 Health: lead
• Universidade Estadual Paulista Júlio de Mesquita Filho: collaborator

Study Sites (1)

Universidade Estadual Paulista - UNESP

Araraquara, São Paulo, 14800900, Brazil

RECRUITING

MeSH Terms

Interventions

Sinus Floor Augmentation; proliferation regulatory factors, human urine

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Bone Transplantation; Orthopedic Procedures; Dentistry

Study Officials

• Sybele Specian, PhD

  Plenum (M3 Health)

  STUDY DIRECTOR

Central Study Contacts

Eduardo Eduardo Hochuli Vieira, PhD

CONTACT

+55(16)33016459; eduardo.hochuli@unesp.br

Sybele S Specian, PhD

CONTACT

+55(11)31099045; sybele.saska@plenum.bio

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 18, 2023
• Study Start: June 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: July 30, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

BR (1)