An observational study in Maxillary Sinus Floor Elevation, sponsored by Kunming Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Kunming Medical University · Observational
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 surgery,immediately 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 a/b 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.
Research significance:The 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.
Kunming Medical University is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Collected all patients who underwent small lateral window maxillary sinus elevation surgery performed by Dr. Xie Liangkun from 2017 to 2024.
Exclusion Criteria:
The window size for a single implant site should not exceed 25 square millimeters, while the window size for consecutive multiple implant sites should not exceed 40 square millimeters.
The window area of the lateral wall maxillary sinus floor elevation surgery
intraoperative window photos were imported into ImageJ software to measure the window area (a value)
Time frame: immediately after surgery
the volume of bone graft material
Import the CBCT scans from immediately after surgery, half a year postoperatively, and after tooth placement into the Mimics software to measure the volume
Time frame: before implant surgery, immediately after surgery，6 months after surgery
Plan to share: Undecided
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Kunming Medical University