Sinus Floor AugmentationNCT05315791
Clinical Application Strategies of Maxillary Sinus Buccal Bony Window
A study testing different methods for maxillary sinus floor elevation in people with Sinus Floor Augmentation and Maxillary Sinus, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
Through randomized controlled trials, investigators will recruit participants who need maxillary sinus floor elevation with different residual bone height, and utilize the maxillary sinus buccal bony window during the surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus Floor Augmentation, Maxillary Sinus
- What is being tested?
- different methods for maxillary sinus floor elevation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2022to 31 Dec 2032
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A single maxillary posterior tooth was missing, and the missing time was ≥ 3 months
- Gingival distance ≥ 4mm
- Residual bone height ≤ 5mm and residual bone width ≥ 6mm
- Good systemic health
- CBCT image was complete and clear, and there was no obvious artifact affecting the measurement
- Informed consent.
Who cannot join
- Untreated diabetes or other serious systemic diseases
- Untreated periodontal disease
- Uncontrolled periapical lesions of adjacent teeth
- Certain bone diseases such as osteoporosis and osteosclerosis
- Severe night bruxism
- Mental illness
- Pregnant or breast-feeding patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jinxing Hu, 18867155632, jxhu@zju.edu.cn
About this study
Official title: Clinical Application Strategies of Maxillary Sinus Buccal Bony Window With Different Residual Bone Heights in Lateral Maxillary Sinus Floor Elevation
Through randomized controlled trials, investigators will recruit participants who need maxillary sinus floor elevation with different residual bone height, and utilize the maxillary sinus buccal bony window during the surgery. Then investigators will gather the related information of participants, collect and analyze their CBCT data, in order to help surgeons select the best operating method for different patients.
Read the detailed description
Through randomized controlled trials, investigators will recruit 60 participants who need maxillary sinus floor elevation with different residual bone height (0~3mm; 3~5mm), and utilize the maxillary sinus buccal bony window during the surgery (A: ground into pieces; B: replace the bone; C: turn inward to hold up the membrane). Then investigators will gather the related information of participants, collect and analyze their CBCT data, in order to help surgeons select the best operating method for different patients.
- Conditions
- Sinus Floor Augmentation, Maxillary Sinus
- Being tested
- different methods for maxillary sinus floor elevation
- Keywords
- maxillary sinus floor elevation, CBCT, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different methods for maxillary sinus floor elevationProcedure or surgery
a: 0~3mm+ground into pieces; b: 0~3mm+replace the bone; c: 0~3mm+turn inward to hold up the membrane; d: 3~5mm+ground into pieces; e: 3~5mm+replace the bone; f: 3~5mm+turn inward to hold up the membrane
| Study group | Role | What they receive |
|---|---|---|
| a: ground into pieces | Experimental | 0~3mm Receives: Procedure: different methods for maxillary sinus floor elevation |
| b: replace the bone | Experimental | 0~3mm Receives: Procedure: different methods for maxillary sinus floor elevation |
| c: turn inward | Experimental | 0~3mm Receives: Procedure: different methods for maxillary sinus floor elevation |
| d: ground into pieces | Experimental | 3~5mm Receives: Procedure: different methods for maxillary sinus floor elevation |
| e: replace the bone | Experimental | 3~5mm Receives: Procedure: different methods for maxillary sinus floor elevation |
| f: turn inward | Experimental | 3~5mm Receives: Procedure: different methods for maxillary sinus floor elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABH change
Apical bone height (ABH): Represented the grafted height at baseline and the grafted height with neo-formed bone at follow-ups.
Measured: baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery
ESBG change
Endo-sinus bone gain (ESBG): ESBG = ABH + implant protrusion length at baseline; ESBG represented the grafted height and neo-formed bone, and described the height difference of radiopaque area in the sinus cavity at different times.
Measured: baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery
RBH
Residual bone height (RBH): Only assessed at baseline
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start10 Mar 2022
- Primary completion2 Mar 2023 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sinus Floor AugmentationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoli Yang, The Dental Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315791
- Sponsor's protocol ID
- 2021-126
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Starch-Jensen T, Jensen JD. Maxillary Sinus Floor Augmentation: a Review of Selected Treatment Modalities. J Oral Maxillofac Res. 2017 Sep 30;8(3):e3. doi: 10.5037/jomr.2017.8303. eCollection 2017 Jul-Sep.
PubMed 29142655Niu L, Wang J, Yu H, Qiu L. New classification of maxillary sinus contours and its relation to sinus floor elevation surgery. Clin Implant Dent Relat Res. 2018 Aug;20(4):493-500. doi: 10.1111/cid.12606. Epub 2018 Apr 25.
PubMed 29691967Zhou Y, Shi Y, Si M, Wu M, Xie Z. The comparative evaluation of transcrestal and lateral sinus floor elevation in sites with residual bone height </=6 mm: A two-year prospective randomized study. Clin Oral Implants Res. 2021 Feb;32(2):180-191. doi: 10.1111/clr.13688. Epub 2020 Dec 26.
PubMed 33220090
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application Strategies of Maxillary Sinus Buccal Bony Window With Different Residual Bone Heights in Lateral Maxillary Sinus Floor Elevation
- ClinicalTrials.gov ID
- NCT05315791
- Acronym / sponsor ID
- 2021-126
- Conditions
- Sinus Floor Augmentation, Maxillary Sinus
- Keywords
- maxillary sinus floor elevation, CBCT, RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 2 Mar 2023 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 7 Apr 2022 (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.
Through randomized controlled trials, investigators will recruit participants who need maxillary sinus floor elevation with different residual bone height, and utilize the maxillary sinus buccal bony window during the surgery. Then investigators will gather the related information of participants, collect and analyze their CBCT data, in order to help surgeons select the best operating method for different patients.
Detailed description
Through randomized controlled trials, investigators will recruit 60 participants who need maxillary sinus floor elevation with different residual bone height (0~3mm; 3~5mm), and utilize the maxillary sinus buccal bony window during the surgery (A: ground into pieces; B: replace the bone; C: turn inward to hold up the membrane). Then investigators will gather the related information of participants, collect and analyze their CBCT data, in order to help surgeons select the best operating method for different patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| a: ground into pieces | Experimental | Procedure: different methods for maxillary sinus floor elevation0~3mm |
| b: replace the bone | Experimental | Procedure: different methods for maxillary sinus floor elevation0~3mm |
| c: turn inward | Experimental | Procedure: different methods for maxillary sinus floor elevation0~3mm |
| d: ground into pieces | Experimental | Procedure: different methods for maxillary sinus floor elevation3~5mm |
| e: replace the bone | Experimental | Procedure: different methods for maxillary sinus floor elevation3~5mm |
| f: turn inward | Experimental | Procedure: different methods for maxillary sinus floor elevation3~5mm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A single maxillary posterior tooth was missing, and the missing time was ≥ 3 months
- Gingival distance ≥ 4mm
- Residual bone height ≤ 5mm and residual bone width ≥ 6mm
- Good systemic health
- CBCT image was complete and clear, and there was no obvious artifact affecting the measurement
Key exclusion criteria (7 listed)
- Untreated diabetes or other serious systemic diseases
- Untreated periodontal disease
- Uncontrolled periapical lesions of adjacent teeth
- Certain bone diseases such as osteoporosis and osteosclerosis
- Severe night bruxism
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 |
|---|---|---|
| different methods for maxillary sinus floor elevationa: 0~3mm+ground into pieces; b: 0~3mm+replace the bone; c: 0~3mm+turn inward to hold up the membrane; d: 3~5mm+ground into pieces; e: 3~5mm+replace the bone; f: 3~5mm+turn inward to hold up the membrane | Procedure or surgery | a: ground into pieces, b: replace the bone, c: turn inward, d: ground into pieces, e: replace the bone, f: turn inward |
Primary outcome
ABH change
Time frame: baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery
Apical bone height (ABH): Represented the grafted height at baseline and the grafted height with neo-formed bone at follow-ups.
ESBG change
Time frame: baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery
Endo-sinus bone gain (ESBG): ESBG = ABH + implant protrusion length at baseline; ESBG represented the grafted height and neo-formed bone, and described the height difference of radiopaque area in the sinus cavity at different times.
RBH
Time frame: baseline
Residual bone height (RBH): Only assessed at baseline
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 7 Apr 2022.
- Results publication: PubMed 29142655Starch-Jensen T, Jensen JD. Maxillary Sinus Floor Augmentation: a Review of Selected Treatment Modalities. J Oral Maxillofac Res. 2017 Sep 30;8(3):e3. doi: 10.5037/jomr.2017.8303. eCollection 2017 Jul-Sep.
- Results publication: PubMed 29691967Niu L, Wang J, Yu H, Qiu L. New classification of maxillary sinus contours and its relation to sinus floor elevation surgery. Clin Implant Dent Relat Res. 2018 Aug;20(4):493-500. doi: 10.1111/cid.12606. Epub 2018 Apr 25.
- Results publication: PubMed 33220090Zhou Y, Shi Y, Si M, Wu M, Xie Z. The comparative evaluation of transcrestal and lateral sinus floor elevation in sites with residual bone height </=6 mm: A two-year prospective randomized study. Clin Oral Implants Res. 2021 Feb;32(2):180-191. doi: 10.1111/clr.13688. Epub 2020 Dec 26.
- Individual participant dataSharing planned: No
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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.
The Affiliated Hospital of Stomatology, Zhejiang University School of Medicine
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different methods for maxillary sinus floor elevation in people with Sinus Floor Augmentation and Maxillary Sinus, run by The Dental Hospital of Zhejiang University School of Medicine 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 7 Apr 2022. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABH change (time frame: baseline, 6 months, and 1, 2, 3, 5, 10 years after the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05315791, which also lists 3 linked publications.
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 7 Apr 2022.