Maxillary Sinus Floor ElevationNCT06876519
Clinical Efficacy of Different Maxillary Sinus Floor Elevation Procedures
An observational study of Maxillary Sinus Floor Elevation, run by Hospital of Stomatology, Sun Yat-Sen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Sinus Floor Elevation
- What is being tested?
- Translateral Maxillary Sinus Floor Elevation and Hydraulic Transcrestal Maxillary Sinus Floor Elevation
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2025to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients having osteointegration failure within six months after surgery.
- Refusal to participate in the study.
- Other conditions deemed unsuitable for participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Maxillary Sinus Floor Elevation
- Being tested
- Translateral Maxillary Sinus Floor Elevation, Hydraulic Transcrestal Maxillary Sinus Floor Elevation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translateral Maxillary Sinus Floor ElevationProcedure or surgery
Translateral maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region.
Hydraulic Transcrestal Maxillary Sinus Floor ElevationProcedure or surgery
Hydraulic transcrestal maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region.
| Study group | Role | What they receive |
|---|---|---|
| Translateral | Patients undergoing translateral maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region, and having successful osseointegration after 6 months. Receives: 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. Receives: Procedure: Hydraulic Transcrestal Maxillary Sinus Floor Elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start10 Mar 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus Floor ElevationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital of Stomatology, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jinming, Hospital of Stomatology, Sun Yat-Sen University
- Investigators
- Jinming Wang, Principal investigator, Hospital of Stomatology, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876519
- Sponsor's protocol ID
- GHKQ-202502-L1
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Different Maxillary Sinus Floor Elevation Procedures Based on Maxillary Sinus Anatomy
- ClinicalTrials.gov ID
- NCT06876519
- Acronym / sponsor ID
- GHKQ-202502-L1
- Conditions
- Maxillary Sinus Floor Elevation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Hospital of Stomatology, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Translateral | – | Procedure: Translateral Maxillary Sinus Floor ElevationPatients undergoing translateral maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region, and having successful osseointegration after 6 months. |
| Hydraulic Transcrestal | – | Procedure: Hydraulic Transcrestal Maxillary Sinus Floor ElevationPatients undergoing hydraulic transcrestal maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region, and having successful osseointegration after 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients having osteointegration failure within six months after surgery.
- Refusal to participate in the study.
- Other conditions deemed unsuitable for participation by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Translateral Maxillary Sinus Floor ElevationTranslateral maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region. | Procedure or surgery | Translateral |
| Hydraulic Transcrestal Maxillary Sinus Floor ElevationHydraulic transcrestal maxillary sinus floor elevation with simultaneous implantation in the maxillary molar region. | Procedure or surgery | Hydraulic Transcrestal |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
Related trials for Maxillary Sinus Floor Elevation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Recruiting
Using Chin Bone Rings for Sinus Lifting and Dental Implants in One Surgery
Maxillary Deficiency, Bone Resorption
RecruitingPhase 2/3
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation
Recruiting
Evaluation of Lateral Sinus Floor Elevation Using Xenograft Versus L-PRF Block Combined With Xenograft
Sinus Floor Augmentation, Maxillary Sinus Floor Elevation
RecruitingObservational study
Impact of Alveolar Ridge Preservation on the Potential Need for Sinus Floor Elevation: A 10-year Retrospective Radiographical Study
Alveolar Bone Loss, Sinus Floor Augmentation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinming Wang principal investigator
Hospital of Stomatology, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillary Sinus Floor Elevation, run by Hospital of Stomatology, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinming Wang (+86 135 3545 8675, wjinm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone loss (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.