- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06876519
Clinical Efficacy of Different Maxillary Sinus Floor Elevation Procedures
March 10, 2025 updated by: Wang Jinming, Hospital of Stomatology, Sun Yat-Sen University
Clinical Efficacy of Different Maxillary Sinus Floor Elevation Procedures Based on Maxillary Sinus Anatomy
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jinming Wang
- Phone Number: +86 135 3545 8675
- Email: wjinm@mail.sysu.edu.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients having osteointegration failure within six months after surgery.
- Refusal to participate in the study.
- Other conditions deemed unsuitable for participation by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Translateral
Patients undergoing translateral maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region, and having successful osseointegration after 6 months.
|
Translateral maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region.
|
|
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.
|
Hydraulic transcrestal maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone loss
Time Frame: 6 months after surgery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jinming Wang, Hospital of Stomatology, Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 10, 2025
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
March 7, 2025
First Submitted That Met QC Criteria
March 10, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 10, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- GHKQ-202502-L1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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