Plenum® Osshp in Maxillary Sinus Elevation Surgery

Oral Surgical Procedures Clinical Trial

Official title:

Double-blind Randomized Controlled Clinical Study of the Predictability of Using Plenum® Osshp in Maxillary Sinus Elevation Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136143
• Other study ID #: Plenum Oss 001
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: November 2023
• Source: M3 Health
• Contact: Eduardo Eduardo Hochuli Vieira, PhD
• Phone: +55(16)33016459
• Email: eduardo.hochuli[@]unesp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 30, 2025
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oral Surgical Procedures

Intervention

Procedure:
• Group 1: Autogenous bone graft
The maxillary sinus will be grafted with the autogenous bone graft.
• Group 2: Plenum® Osshp
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 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 be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with autogenous bone graft.

Locations

Country	Name	City	State
Brazil	Universidade Estadual Paulista - UNESP	Araraquara	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
M3 Health	Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of the bone neoformation of the synthetic graft in comparison with the autogenous graft and in association with i-PRF.	Microcomputed tomography analysis using the following variables: Bone volume fraction, total porosity, trabecular thickness, number of trabeculae and separation of trabeculae.	Six months from postoperative.
Secondary	Rate of the areas of bone neoformation, connective tissue and remnant synthetic graft.	Histomorphometric analysis of the experimental groups.	Six months from postoperative.
Secondary	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.	Quantification of specific marker for Runx2.	Six months from postoperative.
Secondary	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.	Quantification of specific marker for VEGF.	Six months from postoperative.
Secondary	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.	Quantification of specific marker for Osteocalcin (OC)	Six months from postoperative.
Secondary	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.	Quantification of specific marker for Tartrate-Resistant Acid Phosphatase (TRAP).	Six months from postoperative.