Sinus ElevationNCT05362136
Effect of Multiple Perforations of the Sinus Floor on Bone Formation After Sinus Floor Elevation
A study testing perforation of the sinus floor and no perforation of the sinus floor in people with Sinus Elevation and Dental Implant, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of the present study is to compare the rate of new bone formation after sinus floor elevation with or without perforation of the cortical sinus floor prior to insertion of augmentation material. Twelve patients requiring bilateral sinus floor elevation will be recruited for a pilot study in split-mouth design. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus Elevation, Dental Implant, Bone Formation
- What is being tested?
- perforation of the sinus floor and no perforation of the sinus floor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- 23 Mar 2017to Dec 2027
- 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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in need of bilateral sinus floor elevation
- residual alveolar ridge height 2-6mm
- residual alveolar ridge width > 4mm
Who cannot join
- uncontrolled periodontal disease
- acute or chronic sinusitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
University Clinic of Dentistry, Medical University of Vienna
Vienna, 1090
Kristina Bertl, kristina.bertl@meduniwien.ac.at
About this study
Official title: Assessment of the Effect of Sinus Floor Perforation During Sinus Floor Elevation on Bone Formation Within the Augmentation Material
The aim of the present study is to compare the rate of new bone formation after sinus floor elevation with or without perforation of the cortical sinus floor prior to insertion of augmentation material. Twelve patients requiring bilateral sinus floor elevation will be recruited for a pilot study in split-mouth design. On both sides a lateral window will be prepared and the sinus mucosa will be elevated. After this step, the sides are assigned as test or control side. While the control side is just filled with augmentation material, an additional step is performed for the test side, i.e., prior to inserting the augmentation material, the cortical bone layer of the sinus floor is perforated several times into the trabecular bone layer to improve the blood supply to the grafting material. Thereafter, both sides are left to healing for 4-6 months until implant installation. At timepoint of implant installation, a bone biopsy will be collected to allow histological assessment of the grafted area.
- Conditions
- Sinus Elevation, Dental Implant, Bone Formation
- Being tested
- perforation of the sinus floor, no perforation of the sinus floor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perforation of the sinus floorProcedure or surgery
perforation of the cortical layer of the sinus floor prior to inserting the augmentation material during sinus floor elevation
no perforation of the sinus floorProcedure or surgery
standard procedure for sinus floor elevation
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | standard sinus floor elevation Receives: Procedure: no perforation of the sinus floor |
| Test | Experimental | standard sinus floor elevation with additional perforation of the sinus floor Receives: Procedure: perforation of the sinus floor |
What is being measured
The primary outcome is the main question the study is designed to answer.
New bone formation
histological assessment of new bone formation after sinus floor elevation (%)
Measured: 4-6 months after sinus floor elevation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start23 Mar 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus ElevationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Bertl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362136
- Sponsor's protocol ID
- 1709/2016
- Status last verified
- May 2022
- First submitted
- 1 May 2022
- Last updated
- 11 May 2022
- 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 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Sinus Floor Perforation During Sinus Floor Elevation on Bone Formation Within the Augmentation Material
- ClinicalTrials.gov ID
- NCT05362136
- Acronym / sponsor ID
- 1709/2016
- Conditions
- Sinus Elevation, Dental Implant, Bone Formation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 May 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.
The aim of the present study is to compare the rate of new bone formation after sinus floor elevation with or without perforation of the cortical sinus floor prior to insertion of augmentation material. Twelve patients requiring bilateral sinus floor elevation will be recruited for a pilot study in split-mouth design. On both sides a lateral window will be prepared and the sinus mucosa will be elevated. After this step, the sides are assigned as test or control side. While the control side is just filled with augmentation material, an additional step is performed for the test side, i.e., prior to inserting the augmentation material, the cortical bone layer of the sinus floor is perforated several times into the trabecular bone layer to improve the blood supply to the grafting material. Thereafter, both sides are left to healing for 4-6 months until implant installation. At timepoint of implant installation, a bone biopsy will be collected to allow histological assessment of the grafted area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: no perforation of the sinus floorstandard sinus floor elevation |
| Test | Experimental | Procedure: perforation of the sinus floorstandard sinus floor elevation with additional perforation of the sinus floor |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- in need of bilateral sinus floor elevation
- residual alveolar ridge height 2-6mm
- residual alveolar ridge width > 4mm
Key exclusion criteria (2 listed)
- uncontrolled periodontal disease
- acute or chronic sinusitis
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 |
|---|---|---|
| perforation of the sinus floorperforation of the cortical layer of the sinus floor prior to inserting the augmentation material during sinus floor elevation | Procedure or surgery | Test |
| no perforation of the sinus floorstandard procedure for sinus floor elevation | Procedure or surgery | Control |
Primary outcome
New bone formation
Time frame: 4-6 months after sinus floor elevation
histological assessment of new bone formation after sinus floor elevation (%)
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 11 May 2022.
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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.
University Clinic of Dentistry, Medical University of Vienna
Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perforation of the sinus floor and no perforation of the sinus floor in people with Sinus Elevation and Dental Implant, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 2 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 11 May 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 Austria. 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?
New bone formation (time frame: 4-6 months after sinus floor elevation). 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 11 May 2022.