Sinus Floor ElevationNCT07045389
Influence of the Sinus Floor-to-lower Window Margin Distance on Outcomes of Bone Window Repositioning in Lateral Sinus Floor Elevation With Simultaneous Implant Placement
An observational study of Sinus Floor Elevation, run by Guoli Yang at 1 site in China.
Trial summary
The goal of this observational study is to evaluate how the vertical distance from the sinus floor to the lower margin of the lateral window affects bone regeneration and implant outcomes after lateral sinus floor elevation with simultaneous implant placement. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sinus Floor Elevation
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 15 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing lateral sinus floor elevation with simultaneous implant placement at a single academic hospital in China. Inclusion was based on availability of preoperative CBCT and a follow-up period of at least 6 months. Patients were grouped according to the vertical distance from the sinus floor to the lower margin of the lateral window.
Who may be able to join
- Age ≥ 18 years
- Received lateral sinus floor elevation with bone window repositioning and simultaneous implant placement (LSFE with BWR and SIP) between 2019 and 2024
- No contraindications to implantation
- Complete medical and radiographic records available
Who cannot join
- Uncontrolled systemic diseases
- Incomplete medical or surgical records
- Missing preoperative or postoperative imaging data
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital, School of Stomatology, Zhejiang University.
Hangzhou, Zhejiang, 310000
About this study
Official title: Influence of the Sinus Floor-to-lower Window Margin Distance on Outcomes of Bone Window Repositioning in Lateral Sinus Floor Elevation With Simultaneous Implant Placement: A Retrospective Study
The goal of this observational study is to evaluate how the vertical distance from the sinus floor to the lower margin of the lateral window affects bone regeneration and implant outcomes after lateral sinus floor elevation with simultaneous implant placement. The main question it aims to answer is:
Does a sinus floor-to-window margin distance ≥3 mm lead to better bone augmentation and implant stability compared to a distance <3 mm?
This is a retrospective, single-center cohort study. Participants included patients who had previously undergone lateral sinus floor elevation with implant placement and had at least 6 months of postoperative follow-up. Cone-beam CT images were used to measure radiographic outcomes such as alveolar bone height and augmented volume.
- Conditions
- Sinus Floor Elevation
- Keywords
- clinical research, cone-beam computed tomography, sinus floor elevation, bone window repositioning, sinus floor-to-lower window margin distance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DSLW ≥ 3 mm | Patients undergoing lateral sinus floor elevation with simultaneous implant placement, in whom the distance from the sinus floor to the lower edge of the lateral window is greater than or equal to 3 mm. | |
| DSLW < 3 mm | Patients undergoing lateral sinus floor elevation with simultaneous implant placement, in whom the distance from the sinus floor to the lower edge of the lateral window is less than 3 mm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABH at T1, ABH at T2, ABH change from T1 to T2, ESBG at T1, ESBG at T2, ESBG change from T1 to T2, BBH at T1, BBH at T2, BBH change from T1 to T2, PBH at T1, PBH at T2, PBH change from T1 to T2, AV at T1, AV at T2, AV change from T1 to T2
ABH at T1 (mm): Alveolar bone height measured immediately after surgery; ABH at T2 (mm): ABH measured 6 months after surgery; ABH change from T1 to T2 (%): ABH Calculated as ((T2 - T1) / T1) × 100%; ESBG at T1 (mm): Elevated sinus bone gain measured immediately after surgery; ESBG at T2 (mm): ESBG measured 6 months after surgery; ESBG change from T1 to T2 (%): ESBG Calculated as ((T2 - T1) / T1) × 100%; BBH at T1 (mm): Buccal bone height measured immediately after surgery; BBH at T2 (mm): BBH measured 6 months after surgery; BBH change from T1 to T2 (%): BBH Calculated as ((T2 - T1) / T1) × 100%; PBH at T1 (mm): Palatal bone height measured immediately after surgery; PBH at T2 (mm): PBH measured 6 months after surgery; PBH change from T1 to T2 (%): PBH Calculated as ((T2 - T1) / T1) × 100%; AV at T1 (mm³): Augmented volume measured immediately after surgery; AV at T1(mm³): AV measured 6 months after surgery; AV change from T1 to T2 (%): AV Calculated as ((T2 - T1) / T1) × 100%
Measured: T1 (immediately after surgery) and T2 (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 posted1 Jul 2025
- Study start1 Mar 2019
- Primary completion1 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guoli Yang
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, The Dental Hospital of Zhejiang University School of Medicine
- Responsible party
- Sponsor-investigator, Guoli Yang, The Dental Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045389
- Sponsor's protocol ID
- 2024-204R
- Other IDs
- 82271001; 82370991; 2022KY872
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the retrospective nature of the study and ethical considerations related to patient privacy.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Sinus Floor-to-lower Window Margin Distance on Outcomes of Bone Window Repositioning in Lateral Sinus Floor Elevation With Simultaneous Implant Placement: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07045389
- Acronym / sponsor ID
- 2024-204R
- Conditions
- Sinus Floor Elevation
- Keywords
- clinical research, cone-beam computed tomography, sinus floor elevation, bone window repositioning, sinus floor-to-lower window margin distance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Guoli YangUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, The Dental Hospital of Zhejiang University School of Medicine
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 1 Jul 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 observational study is to evaluate how the vertical distance from the sinus floor to the lower margin of the lateral window affects bone regeneration and implant outcomes after lateral sinus floor elevation with simultaneous implant placement. The main question it aims to answer is:
Does a sinus floor-to-window margin distance ≥3 mm lead to better bone augmentation and implant stability compared to a distance <3 mm?
This is a retrospective, single-center cohort study. Participants included patients who had previously undergone lateral sinus floor elevation with implant placement and had at least 6 months of postoperative follow-up. Cone-beam CT images were used to measure radiographic outcomes such as alveolar bone height and augmented volume.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSLW ≥ 3 mm | – | –Patients undergoing lateral sinus floor elevation with simultaneous implant placement, in whom the distance from the sinus floor to the lower edge of the lateral window is greater than or equal to 3 mm. |
| DSLW < 3 mm | – | –Patients undergoing lateral sinus floor elevation with simultaneous implant placement, in whom the distance from the sinus floor to the lower edge of the lateral window is less than 3 mm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lateral sinus floor elevation with simultaneous implant placement at a single academic hospital in China. Inclusion was based on availability of preoperative CBCT and a follow-up period of at least 6 months. Patients were grouped according to the vertical distance from the sinus floor to the lower margin of the lateral window.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Received lateral sinus floor elevation with bone window repositioning and simultaneous implant placement (LSFE with BWR and SIP) between 2019 and 2024
- No contraindications to implantation
- Complete medical and radiographic records available
Key exclusion criteria (3 listed)
- Uncontrolled systemic diseases
- Incomplete medical or surgical records
- Missing preoperative or postoperative imaging data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ABH at T1, ABH at T2, ABH change from T1 to T2, ESBG at T1, ESBG at T2, ESBG change from T1 to T2, BBH at T1, BBH at T2, BBH change from T1 to T2, PBH at T1, PBH at T2, PBH change from T1 to T2, AV at T1, AV at T2, AV change from T1 to T2
Time frame: T1 (immediately after surgery) and T2 (6 months after surgery)
ABH at T1 (mm): Alveolar bone height measured immediately after surgery; ABH at T2 (mm): ABH measured 6 months after surgery; ABH change from T1 to T2 (%): ABH Calculated as ((T2 - T1) / T1) × 100%; ESBG at T1 (mm): Elevated sinus bone gain measured immediately after surgery; ESBG at T2 (mm): ESBG measured 6 months after surgery; ESBG change from T1 to T2 (%): ESBG Calculated as ((T2 - T1) / T1) × 100%; BBH at T1 (mm): Buccal bone height measured immediately after surgery; BBH at T2 (mm): BBH measured 6 months after surgery; BBH change from T1 to T2 (%): BBH Calculated as ((T2 - T1) / T1) × 100%; PBH at T1 (mm): Palatal bone height measured immediately after surgery; PBH at T2 (mm): PBH measured 6 months after surgery; PBH change from T1 to T2 (%): PBH Calculated as ((T2 - T1) / T1) × 100%; AV at T1 (mm³): Augmented volume measured immediately after surgery; AV at T1(mm³): AV measured 6 months after surgery; AV change from T1 to T2 (%): AV Calculated as ((T2 - T1) / T1) × 100%
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 1 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the retrospective nature of the study and ethical considerations related to patient privacy.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sinus Floor Elevation, run by Guoli Yang 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 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: finished, as of the sponsor's last update on 1 Jul 2025. 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?
ABH at T1, ABH at T2, ABH change from T1 to T2, ESBG at T1, ESBG at T2, ESBG change from T1 to T2, BBH at T1, BBH at T2, BBH change from T1 to T2, PBH at T1, PBH at T2, PBH change from T1 to T2, AV at T1, AV at T2, AV change from T1 to T2 (time frame: T1 (immediately after surgery) and T2 (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 1 Jul 2025.