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The Systematic Evaluation of the Surgery, Using the Ratio of the Window Area to the Volume of Bone Graft Material

NCT06654492 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2024-10-23

No results posted yet for this study

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 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.

Conditions

  • Maxillary Sinus Floor Elevation

Interventions

PROCEDURE

The dimension of the window for lateral window maxillary sinus elevation surgery

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.

Sponsors & Collaborators

  • Kunming Medical University

    lead OTHER

Principal Investigators

  • Liangkun Xie · Kunming Medical University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2024-09-24
Completion
2024-09-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06654492 on ClinicalTrials.gov