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NCT06654492

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

Completed Last updated 23 October 2024
What this trial tests

trial testing The dimension of the window for lateral window maxillary sinus elevation surgery in Maxillary Sinus Floor Elevation in 77 participants. Completed in 24 September 2024.

Timeline
2 August 2017
Primary endpoint
24 September 2024
24 September 2024

Quick facts

Lead sponsorKunming Medical University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment77
Start date2 August 2017
Primary completion24 September 2024
Estimated completion24 September 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Kunming Medical University

Who can join

18 and older, any sex, with Maxillary Sinus Floor Elevation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Kunming Medical University trials

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Data sources for this page

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