Clinical trial NCT06136143: Plenum® Osshp in Maxillary Sinus Elevation Surgery
Official title: Double-blind Randomized Controlled Clinical Study of the Predictability of Using Plenum® Osshp in Maxillary Sinus Elevation Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Surgical Procedures
Keywords: Maxillary Sinus
Synthetic Bone Graft
Autogenous Bone Graft
Platelet Rich Fibrin
Lead sponsor: M3 Health
Sponsor class: INDUSTRY
Collaborators: name: Universidade Estadual Paulista Júlio de Mesquita Filho
First posted: 2023-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of the maintenance of volume in the maxillary sinus region.
timeFrame: Fifteen days (T1) and six months (T2) from postoperative.
Secondary outcomes:
measure: Rate of the bone neoformation of the synthetic graft in comparison with the autogenous graft and in association with i-PRF.
timeFrame: Six months from postoperative.
measure: Rate of the areas of bone neoformation, connective tissue and remnant synthetic graft.
timeFrame: Six months from postoperative.
measure: 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.
timeFrame: Six months from postoperative.
measure: 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.
timeFrame: Six months from postoperative.
measure: 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.
timeFrame: Six months from postoperative.
measure: 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.
timeFrame: Six months from postoperative.
Other outcomes:
Locations:
city: Araraquara
country: Brazil
facility: Universidade Estadual Paulista - UNESP
state: Sao Paulo
Study officials:
affiliation: Plenum (M3 Health)
name: Sybele Specian, PhD
role: STUDY_DIRECTOR
References: