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

NCT06654492 | Completed

• 1 other identifier: KYKQ2024MEC0050
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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 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

Keywords

LW-MSFE

Outcome Measures

Primary Outcomes (1)

• 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)

  immediately after surgery

Secondary Outcomes (1)

• the volume of bone graft material

  before implant surgery, immediately after surgery，6 months after surgery

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Collected all patients who underwent small lateral window maxillary sinus elevation surgery performed by Dr. Xie Liangkun from 2017 to 2024.

You may qualify if:

• Aged 18 years or older;
• Missing posterior maxillary teeth;
• The missing tooth area has been edentulous for at least 3 months;
• No acute severe maxillary sinus inflammation, and no tumor or other space-occupying lesions within the maxillary sinus;
• The residual bone height (RBH) in the missing tooth area is less than 4mm;
• Sufficient alveolar bone width in the missing tooth area to ensure implant placement;
• Signed an informed consent form and can return for follow-up visits as scheduled.

You may not qualify if:

• Patients with systemic diseases not suitable for implantation: such as uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases, bone metabolic diseases, head and face radiotherapy, etc.;
• Uncontrolled periodontitis or mucosal disease patients;
• Patients with bruxism;
• Patients who have undergone implant placement or artificial bone material implantation in the missing tooth area;
• Patients with mental illness.

Sponsors & Collaborators

• Kunming Medical University: lead

Study Sites (1)

Kunming Medical University

Kunming, Yunan, 650106, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The cylindrical bone tissue extracted from the implant site half a year after the small lateral window maxillary sinus floor elevation surgery has a diameter of approximately 3 millimeters and a height of 5 millimeters. This bone tissue is used for Micro-CT scanning.

Study Officials

• Liangkun Xie

  Kunming Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate student

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 23, 2024
• Study Start: August 2, 2017
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

CN (1)