Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136143
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-09
Brief Title:
Plenum Osshp in Maxillary Sinus Elevation Surgery
Sponsor:
M3 Health
Organization:
M3 Health
Study Overview
Official Title:
Double-blind Randomized Controlled Clinical Study of the Predictability of Using Plenum Osshp in Maxillary Sinus Elevation Surgery
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 BVTV total porosity PoTot trabecular thickness TbTh number of trabeculae TbN and separation of trabeculae TbSp 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 p005 will be adopted for all tests
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None