Sinus Floor AugmentationNCT05954273
Maxillary Sinus Membrane Perforation Incidence During Osseodensification
An observational study of Sinus Floor Augmentation and Sinus Infection, run by Versah at 1 site in United States.
Trial summary
Measure the incidence of the maxillary sinus membrane perforation during the Osseodensification crestal sinus grafting procedure. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus Floor Augmentation, Sinus Infection
- What is being tested?
- Osseodensification crestal sinsus graft
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to 28 Aug 2023
- 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 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medically healthy patients older than 21 years old who are treated with crestal sinus augmentation via osseodensification using the Densah Burs and implant placement.
Who may be able to join
- 1- Medically healthy patients treated with crestal sinus augmentation via osseodensification using the Densah Burs and implant placement.
Who cannot join
- History of radiotherapy,
- Bisphosphonate medication.
- Active periodontal disease.
- Uncontrolled diabetes.
- Heavy smoking (> 20 cigarettes/day).
- Local acute apical abscess.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Maxillary Sinus Membrane Perforation During Osseodensification Crestal Sinus Grafting
Measure the incidence of the maxillary sinus membrane perforation during the Osseodensification crestal sinus grafting procedure.
Read the detailed description
Retrospective clinical study to :
- Investigate maxillary sinus membrane perforation incidence via osseodensification crestal sinus grafting utilizing the Densah bur.
- Assess the osseodensification technique efficacy for maxillary crestal sinus grafting with implant site preparation.
- Study and analyze the maxillary sinus perforation rate during or post-Osseodensification-mediated sinus grafting as a function.
- To share the knowledge from this retrospective analysis through scientific publications.
- Conditions
- Sinus Floor Augmentation, Sinus Infection
- Being tested
- Osseodensification crestal sinsus graft
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osseodensification crestal sinsus graftProcedure or surgery
Also called Maxillary sinus grafting via crestal approach, Maxillary sinus membrance perforation incidence
Osseodensification Mediated Maxillary Sinus Crestal Grafting
| Study group | Role | What they receive |
|---|---|---|
| Sinus membrane perforation | Sinus membrane perforation incidences to measure the perforation rate. Receives: Procedure: Osseodensification crestal sinsus graft | |
| Alveolar bone height below the maxillary sinus floor | Pre-sinus augmentation alveolar bone ridge height. Receives: Procedure: Osseodensification crestal sinsus graft | |
| Maxillary sinus augementation level | Vertical graft height in the maxillary sinus. Receives: Procedure: Osseodensification crestal sinsus graft | |
| Implants length and width | Placed implants length and width Receives: Procedure: Osseodensification crestal sinsus graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary sinus membrane perforation rate during osseodensification crestal sinus grafting procedure.
Measure the incidence of sinus membrane perforation during osseodensification
Measured: During augmentation surgery
Secondary outcomes (1)
Maxillary sinus augmentation level
The height and width of augmentation level
Measured: During augmentation surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start3 Apr 2023
- Primary completion31 Jul 2023 (estimated)
- Study completion28 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versah
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954273
- Sponsor's protocol ID
- ODSINUSPERF
- Status last verified
- Jul 2023
- First submitted
- 12 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Coelho PG, Jimbo R, Tovar N, Bonfante EA. Osseointegration: hierarchical designing encompassing the macrometer, micrometer, and nanometer length scales. Dent Mater. 2015 Jan;31(1):37-52. doi: 10.1016/j.dental.2014.10.007. Epub 2014 Nov 25.
PubMed 25467952Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
PubMed 27741329Huwais S, Mazor Z, Ioannou AL, Gluckman H, Neiva R. A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting. Int J Oral Maxillofac Implants. 2018 Nov/Dec;33(6):1305-1311. doi: 10.11607/jomi.6770.
PubMed 30427961Baron Tarun Kumar; Venkatraman Narayan. (2017), Minimally invasive crestal approach sinus floor elevation using Densah burs, and Hydraulic lift utilizing putty graft in cartridge delivery. Clin Oral Impl Res, 28: 203-203.
Gaspar, J. , Esteves, T. , Gaspar, R. , Rua, J. and João Mendes, J. (2018), Osseodensification for implant site preparation in the maxilla - a prospective study of 97 implants. Clin Oral Impl Res, 29: 163-163.
Alhayati JZ, Al-Anee AM. Evaluation of crestal sinus floor elevations using versah burs with simultaneous implant placement, at residual bone height >/= 2.0 _ < 6.0 mm. A prospective clinical study. Oral Maxillofac Surg. 2023 Jun;27(2):325-332. doi: 10.1007/s10006-022-01071-0. Epub 2022 May 14.
PubMed 35567659Arafat, Shereen W.; Mohamed A Elbaz. Clinical and radiographic evaluation of Osseodensification versus osteotome for Sinus floor elevation in partially atrophic maxilla: A prospective long term study. Egyptian Dental Journal, 65, issue 1- January (Oral Surgery), 2019, 189-195. Doi: 1021608/edj.2015.71261
Neiva R, Tanello B, Duarte W, Silva F. Osseodensification Crestal Sinus Floor Elevation with or without Synthetic and Resorbable Calcium Phosphosilicate Putty. Clin Oral Implants Res. 2018;29 (Suppl.1)
Natali C, Ingle P, Dowell J. Orthopaedic bone drills-can they be improved? Temperature changes near the drilling face. J Bone Joint Surg Br. 1996 May;78(3):357-62.
PubMed 8636166
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Maxillary Sinus Membrane Perforation During Osseodensification Crestal Sinus Grafting
- ClinicalTrials.gov ID
- NCT05954273
- Acronym / sponsor ID
- ODSINUSPERF
- Conditions
- Sinus Floor Augmentation, Sinus Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- VersahIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 28 Aug 2023 (estimated)
- First posted
- 20 Jul 2023 (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.
Measure the incidence of the maxillary sinus membrane perforation during the Osseodensification crestal sinus grafting procedure.
Detailed description
Retrospective clinical study to :
- Investigate maxillary sinus membrane perforation incidence via osseodensification crestal sinus grafting utilizing the Densah bur.
- Assess the osseodensification technique efficacy for maxillary crestal sinus grafting with implant site preparation.
- Study and analyze the maxillary sinus perforation rate during or post-Osseodensification-mediated sinus grafting as a function.
- To share the knowledge from this retrospective analysis through scientific publications.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sinus membrane perforation | – | Procedure: Osseodensification crestal sinsus graftSinus membrane perforation incidences to measure the perforation rate. |
| Alveolar bone height below the maxillary sinus floor | – | Procedure: Osseodensification crestal sinsus graftPre-sinus augmentation alveolar bone ridge height. |
| Maxillary sinus augementation level | – | Procedure: Osseodensification crestal sinsus graftVertical graft height in the maxillary sinus. |
| Implants length and width | – | Procedure: Osseodensification crestal sinsus graftPlaced implants length and width |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medically healthy patients older than 21 years old who are treated with crestal sinus augmentation via osseodensification using the Densah Burs and implant placement.
Key inclusion criteria (1 listed)
- 1- Medically healthy patients treated with crestal sinus augmentation via osseodensification using the Densah Burs and implant placement.
Key exclusion criteria (6 listed)
- History of radiotherapy,
- Bisphosphonate medication.
- Active periodontal disease.
- Uncontrolled diabetes.
- Heavy smoking (> 20 cigarettes/day).
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 |
|---|---|---|
| Osseodensification crestal sinsus graftAlso: Maxillary sinus grafting via crestal approach, Maxillary sinus membrance perforation incidenceOsseodensification Mediated Maxillary Sinus Crestal Grafting | Procedure or surgery | Alveolar bone height below the maxillary sinus floor, Implants length and width, Maxillary sinus augementation level, Sinus membrane perforation |
Primary outcome
Maxillary sinus membrane perforation rate during osseodensification crestal sinus grafting procedure.
Time frame: During augmentation surgery
Measure the incidence of sinus membrane perforation during osseodensification
1 secondary outcome
Maxillary sinus augmentation level
Time frame: During augmentation surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Background: PubMed 25467952Coelho PG, Jimbo R, Tovar N, Bonfante EA. Osseointegration: hierarchical designing encompassing the macrometer, micrometer, and nanometer length scales. Dent Mater. 2015 Jan;31(1):37-52. doi: 10.1016/j.dental.2014.10.007. Epub 2014 Nov 25.
- Background: PubMed 27741329Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
- Background: PubMed 30427961Huwais S, Mazor Z, Ioannou AL, Gluckman H, Neiva R. A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting. Int J Oral Maxillofac Implants. 2018 Nov/Dec;33(6):1305-1311. doi: 10.11607/jomi.6770.
- BackgroundBaron Tarun Kumar; Venkatraman Narayan. (2017), Minimally invasive crestal approach sinus floor elevation using Densah burs, and Hydraulic lift utilizing putty graft in cartridge delivery. Clin Oral Impl Res, 28: 203-203.
- BackgroundGaspar, J. , Esteves, T. , Gaspar, R. , Rua, J. and João Mendes, J. (2018), Osseodensification for implant site preparation in the maxilla - a prospective study of 97 implants. Clin Oral Impl Res, 29: 163-163.
- Background: PubMed 35567659Alhayati JZ, Al-Anee AM. Evaluation of crestal sinus floor elevations using versah burs with simultaneous implant placement, at residual bone height >/= 2.0 _ < 6.0 mm. A prospective clinical study. Oral Maxillofac Surg. 2023 Jun;27(2):325-332. doi: 10.1007/s10006-022-01071-0. Epub 2022 May 14.
- BackgroundArafat, Shereen W.; Mohamed A Elbaz. Clinical and radiographic evaluation of Osseodensification versus osteotome for Sinus floor elevation in partially atrophic maxilla: A prospective long term study. Egyptian Dental Journal, 65, issue 1- January (Oral Surgery), 2019, 189-195. Doi: 1021608/edj.2015.71261
- BackgroundNeiva R, Tanello B, Duarte W, Silva F. Osseodensification Crestal Sinus Floor Elevation with or without Synthetic and Resorbable Calcium Phosphosilicate Putty. Clin Oral Implants Res. 2018;29 (Suppl.1)
- Background: PubMed 8636166Natali C, Ingle P, Dowell J. Orthopaedic bone drills-can they be improved? Temperature changes near the drilling face. J Bone Joint Surg Br. 1996 May;78(3):357-62.
- 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.
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 Augmentation and Sinus Infection, run by Versah at 1 site in United States.
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 6 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 24 Jul 2023. 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 United States. 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?
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?
Maxillary sinus membrane perforation rate during osseodensification crestal sinus grafting procedure. (time frame: During augmentation surgery). 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 NCT05954273, which also lists 9 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 24 Jul 2023.