Partial-edentulismNCT04662749
Influence of Intruding Angle on Non-graft Osteotome Sinus Elevation
An observational study of Partial-edentulism and Osteotome Sinus Lift, run by Hospital of Stomatology, Sun Yat-Sen University at 1 site in China.
Trial summary
The contour of maxillary sinus matters in osteotome sinus elevation. So does the implant intruding angle between the axis of the implant and the tangent line of the sinus floor contour. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Partial-edentulism, Osteotome Sinus Lift
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2020to 26 Mar 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who visited Guanghua Hospital of Stomatology, Sun Yat-Sen University from July 2006 to August 2018.
Who may be able to join
- Patients with residual bone height >4mm and osteotome sinus elevation together with simultaneous implant placement without grafting
Who cannot join
- Smokers or patients with systemic disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hospital of Stomatology, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Bin Cheng, PhD
About this study
Official title: Influence of Implant Intruding Angle on Osteotome Sinus Elevation Without Grafting
The contour of maxillary sinus matters in osteotome sinus elevation. So does the implant intruding angle between the axis of the implant and the tangent line of the sinus floor contour. The investigators have been engaged in studying the relationship between the outcome of bone formation and the intruding angle, which could guide our clinical decision-making.
- Conditions
- Partial-edentulism, Osteotome Sinus Lift
- Keywords
- osteotome sinus lift, endosinus bone gain, sinus floor configuration, intruding angle
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 |
|---|---|---|
| concave group | the group whose level of sinus floor is lower than both of the adjacent teeth | |
| angle group | the group whose level of sinus floor is lower than one of the adjacent teeth and higher than the other one of the adjacent teeth | |
| flat group | the group whose level of sinus floor is similar to both of the adjacent teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
endosinus bone change
endosinus bone change after osteotome sinus elevation without grafting
Measured: from the time of performing the implanting surgery to the latest recalling period, accessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start16 Feb 2020
- Primary completion20 Mar 2021 (estimated)
- Study completion26 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-edentulismStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital of Stomatology, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feilong Deng, Hospital of Stomatology, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662749
- Sponsor's protocol ID
- KQEC-2020-26
- Status last verified
- Dec 2020
- First submitted
- 25 Nov 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Implant Intruding Angle on Osteotome Sinus Elevation Without Grafting
- ClinicalTrials.gov ID
- NCT04662749
- Acronym / sponsor ID
- KQEC-2020-26
- Conditions
- Partial-edentulism, Osteotome Sinus Lift
- Keywords
- osteotome sinus lift, endosinus bone gain, sinus floor configuration, intruding angle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hospital of Stomatology, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 16 Feb 2020 (actual)
- Primary completion
- 20 Mar 2021 (estimated)
- Study completion
- 26 Mar 2021 (estimated)
- First posted
- 10 Dec 2020 (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 contour of maxillary sinus matters in osteotome sinus elevation. So does the implant intruding angle between the axis of the implant and the tangent line of the sinus floor contour. The investigators have been engaged in studying the relationship between the outcome of bone formation and the intruding angle, which could guide our clinical decision-making.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| concave group | – | –the group whose level of sinus floor is lower than both of the adjacent teeth |
| angle group | – | –the group whose level of sinus floor is lower than one of the adjacent teeth and higher than the other one of the adjacent teeth |
| flat group | – | –the group whose level of sinus floor is similar to both of the adjacent teeth |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who visited Guanghua Hospital of Stomatology, Sun Yat-Sen University from July 2006 to August 2018.
Key inclusion criteria (1 listed)
- Patients with residual bone height >4mm and osteotome sinus elevation together with simultaneous implant placement without grafting
Key exclusion criteria (1 listed)
- Smokers or patients with systemic disease.
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
endosinus bone change
Time frame: from the time of performing the implanting surgery to the latest recalling period, accessed up to 100 months
endosinus bone change after osteotome sinus elevation without grafting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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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.
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 Partial-edentulism and Osteotome Sinus Lift, run by Hospital of Stomatology, Sun Yat-Sen 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feilong Deng, PhD (+8620 8386 2537, dengfl@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endosinus bone change (time frame: from the time of performing the implanting surgery to the latest recalling period, accessed up to 100 months). 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 Feb 2021.