Clinical Efficacy of Different Maxillary Sinus Floor Elevation Procedures

NCT06876519 | Not Yet Recruiting

• 1 other identifier: GHKQ-202502-L1
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to investigate the clinical efficacy of different maxillary sinus floor elevation procedures based on maxillary sinus anatomy. The main questions it aims to answer are:

• How does the anatomical morphology of maxillary sinus affect postoperative bone resorption?
• How to select the appropriate maxillary sinus floor elevation procedure based on maxillary sinus anatomy? Preoperative, immediate postoperative, and six-month postoperative CBCT images of patients undergoing translateral maxillary sinus floor elevation or hydraulic transcrestal maxillary sinus floor elevation will be measured.

Conditions

Maxillary Sinus Floor Elevation

Outcome Measures

Primary Outcomes (1)

• Bone loss

  The incidence of bone length, width and height gained in maxillary sinus are evaluated through CBCT imaging for preoperative, the day of surgery, and six months after surgery.

  6 months after surgery

Study Arms (2)

Translateral

Patients undergoing translateral maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region, and having successful osseointegration after 6 months.

Procedure: Translateral Maxillary Sinus Floor Elevation

Hydraulic Transcrestal

Patients undergoing hydraulic transcrestal maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region, and having successful osseointegration after 6 months.

Procedure: Hydraulic Transcrestal Maxillary Sinus Floor Elevation

Interventions

Translateral Maxillary Sinus Floor Elevation PROCEDURE

Translateral maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region.

Translateral

Hydraulic Transcrestal Maxillary Sinus Floor Elevation PROCEDURE

Hydraulic transcrestal maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region.

Hydraulic Transcrestal

Eligibility Criteria

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

Study Population

Patients undergoing maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region, and having successful osseointegration after 6 months from surgery.

You may qualify if:

• Patients undergoing translateral maxillary sinus floor elevation or hydraulic transcrestal maxillary sinus floor elevation in the maxillary molar region.
• Patients undergoing maxillary sinus floor elevationwith simultaneous implantation in the maxillary molar region，and having successful osseointegration after 6 months from surgery.
• Patients having CBCT examination for preoperative, the day of surgery, and six months after surgery.
• Patients treated between January 1, 2016 and June 30, 2024.

You may not qualify if:

• Patients having osteointegration failure within six months after surgery.
• Refusal to participate in the study.
• Other conditions deemed unsuitable for participation by the investigator.

Sponsors & Collaborators

• Hospital of Stomatology, Sun Yat-Sen University: lead

Study Officials

• Jinming Wang

  Hospital of Stomatology, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinming Wang

CONTACT

+86 135 3545 8675; wjinm@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 14, 2025
• Study Start: March 10, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03