Viewing Study NCT06654492



Ignite Creation Date: 2024-10-26 @ 3:43 PM
Last Modification Date: 2024-10-26 @ 3:43 PM
Study NCT ID: NCT06654492
Status: COMPLETED
Last Update Posted: None
First Post: 2024-10-17

Brief Title: The Systematic Evaluation of the Surgery Using the Ratio of the Window Area to the Volume of Bone Graft Material
Sponsor: None
Organization: None

Study Overview

Official Title: Retrospective Study of Small Window Lateral Maxillary Sinus Floor Elevation Surgery
Status: COMPLETED
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Objective To conduct a systematic mid-to-long-term efficacy evaluation of the small window lateral maxillary sinus floor elevation surgery using the ratio of the window area to the volume of bone graft material as an innovative evaluation metric to provide clinical evidence for the treatment and assessment of maxillary sinus elevation surgery Research Content and Methods The study included all patients who underwent lateral wall small window surgery performed by Dr Xie Liangkun from 2017 to 2024 in Affiliated Stomatology Hospital of Kunming Medical University Seventy-seven patients underwent cone-beam computed tomography CBCT at each stage before grafting before the surgeryimmediately after the surgery 6 months postoperatively and after tooth placement The CBCT data were imported into Mimics software to measure the volume of bone graft material at different periods b value and The photos which recording window size during surgery were imported into ImageJ software to measure the window area a value CBCT was also used to measure the distance from the window to the sinus floor the thickness of the lateral wall bone plate and the thickness of the Schneiderian membrane as secondary measurement indicators The ratio of ab was statistically analyzed for correlation with various secondary indicators and conclusions were drawn Bone cores taken 6 months after grafting before implant placement were subjected to Micro-CT scanning and histological analysis to evaluate the bone formation effects
Detailed Description: Research significanceThe first part is the elevation of maxillary sinus floor through minimally invasive window side wall small window Through retrospective study of implant retention rate complications patient subjective perception anatomical factors and other indicators it is used to comprehensively evaluate the clinical efficacy of this surgical procedure In the second part representative bone columns are taken for Micro CT scanning to evaluate the osseointegration from a histological perspective Mimics software performs three-dimensional scanning of the transplant area and the ratio of the window area to the volume of the transplant part is used as the main measurement index to demonstrate that minimally invasive window opening can achieve ideal bone grafting effects Further verify the success or failure of minimally invasive side wall fenestration surgery At present relevant studies use this ratio as the main research data and there is no use of 3D scanning to study changes in bone transplant areas There are also few studies evaluating the binding of bone tissue using Micro CT and most of them use CBCT 2D measurement data for evaluation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None