Maxillary Sinus Floor ElevationNCT06654492
The Systematic Evaluation of the Surgery, Using the Ratio of the Window Area to the Volume of Bone Graft Material
An observational study of Maxillary Sinus Floor Elevation, run by Kunming Medical University at 1 site in China.
Trial 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… 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?
- The dimension of the window for lateral window maxillary sinus elevation surgery
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2017to 24 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Collected all patients who underwent small lateral window maxillary sinus elevation surgery performed by Dr. Xie Liangkun from 2017 to 2024.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study of Small Window Lateral Maxillary Sinus Floor Elevation Surgery
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.
Read the detailed description
Research significance:The first part is the elevation of maxillary sinus floor through minimally invasive window side wall small window. Through retrospective study of implant retention rate, complications, patient subjective perception, anatomical factors and other indicators, it is used to comprehensively evaluate the clinical efficacy of this surgical procedure. In the second part, representative bone columns are taken for Micro CT scanning to evaluate the osseointegration from a histological perspective. Mimics software performs three-dimensional scanning of the transplant area, and the ratio of the window area to the volume of the transplant part is used as the main measurement index to demonstrate that minimally invasive window opening can achieve ideal bone grafting effects. Further verify the success or failure of minimally invasive side wall fenestration surgery. At present, relevant studies use this ratio as the main research data, and there is no use of 3D scanning to study changes in bone transplant areas. There are also few studies evaluating the binding of bone tissue using Micro CT, and most of them use CBCT 2D measurement data for evaluation.
- Conditions
- Maxillary Sinus Floor Elevation
- Being tested
- The dimension of the window for lateral window maxillary sinus elevation surgery
- Keywords
- LW-MSFE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The dimension of the window for lateral window maxillary sinus elevation surgeryProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: immediately after surgery
Secondary outcomes (1)
the volume of bone graft material
Import the CBCT scans from immediately after surgery, half a year postoperatively, and after tooth placement into the Mimics software to measure the volume
Measured: before implant surgery, immediately after surgery，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 posted23 Oct 2024
- Study start2 Aug 2017
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fangyu Yao, Kunming Medical University
- Investigators
- Liangkun Xie, Principal investigator, Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654492
- Sponsor's protocol ID
- KYKQ2024MEC0050
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Small Window Lateral Maxillary Sinus Floor Elevation Surgery
- ClinicalTrials.gov ID
- NCT06654492
- Acronym / sponsor ID
- KYKQ2024MEC0050
- Conditions
- Maxillary Sinus Floor Elevation
- Keywords
- LW-MSFE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Kunming Medical UniversityUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 23 Oct 2024 (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.
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.
Detailed description
Research significance:The first part is the elevation of maxillary sinus floor through minimally invasive window side wall small window. Through retrospective study of implant retention rate, complications, patient subjective perception, anatomical factors and other indicators, it is used to comprehensively evaluate the clinical efficacy of this surgical procedure. In the second part, representative bone columns are taken for Micro CT scanning to evaluate the osseointegration from a histological perspective. Mimics software performs three-dimensional scanning of the transplant area, and the ratio of the window area to the volume of the transplant part is used as the main measurement index to demonstrate that minimally invasive window opening can achieve ideal bone grafting effects. Further verify the success or failure of minimally invasive side wall fenestration surgery. At present, relevant studies use this ratio as the main research data, and there is no use of 3D scanning to study changes in bone transplant areas. There are also few studies evaluating the binding of bone tissue using Micro CT, and most of them use CBCT 2D measurement data for evaluation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Collected all patients who underwent small lateral window maxillary sinus elevation surgery performed by Dr. Xie Liangkun from 2017 to 2024.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| The dimension of the window for lateral window maxillary sinus elevation surgeryThe 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. | Procedure or surgery | – |
Primary outcome
The window area of the lateral wall maxillary sinus floor elevation surgery
Time frame: immediately after surgery
intraoperative window photos were imported into ImageJ software to measure the window area (a value)
1 secondary outcome
the volume of bone graft material
Time frame: before implant surgery, immediately after surgery，6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Liangkun Xie principal investigator
Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillary Sinus Floor Elevation, run by Kunming Medical University at 1 site in China.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The window area of the lateral wall maxillary sinus floor elevation surgery (time frame: immediately 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 23 Oct 2024.