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Enrolling by invitationNCT05954273Updated Jul 24, 2023

Maxillary Sinus Membrane Perforation Incidence During Osseodensification

An observational study in Sinus Floor Augmentation and Sinus Infection, sponsored by Versah. Enrolling by invitation at 1 site in United States. Open to participants aged 21 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by Versah · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2023, 3 years 3 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
500
Ages
21 Years to 90 Years
Sex
All
01

Study summary

Measure the incidence of the maxillary sinus membrane perforation during the Osseodensification crestal sinus grafting procedure.

Read the detailed description

Retrospective clinical study to :

  1. Investigate maxillary sinus membrane perforation incidence via osseodensification crestal sinus grafting utilizing the Densah bur.
  2. Assess the osseodensification technique efficacy for maxillary crestal sinus grafting with implant site preparation.
  3. Study and analyze the maxillary sinus perforation rate during or post-Osseodensification-mediated sinus grafting as a function.
  4. To share the knowledge from this retrospective analysis through scientific publications.
02

Conditions studied

  • Sinus Floor Augmentation
  • Sinus Infection

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03

In context

Sinusitis

256 studies on the registry are indexed under Sinusitis; 23 are open to participants now.

This study's planned enrollment of 500 is above the median of 125 across 44 observational studies indexed under Sinusitis.

Browse Sinusitis studies →

Lead sponsor

This is the only study on the registry with Versah as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1- Medically healthy patients treated with crestal sinus augmentation via osseodensification using the Densah Burs and implant placement.

Exclusion criteria

Exclusion Criteria:

  1. History of radiotherapy,
  2. Bisphosphonate medication.
  3. Active periodontal disease.
  4. Uncontrolled diabetes.
  5. Heavy smoking (> 20 cigarettes/day).
  6. Local acute apical abscess.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Sinus membrane perforation

    Sinus membrane perforation incidences to measure the perforation rate.

    Procedure: Osseodensification crestal sinsus graft

  • Alveolar bone height below the maxillary sinus floor

    Pre-sinus augmentation alveolar bone ridge height.

    Procedure: Osseodensification crestal sinsus graft

  • Maxillary sinus augementation level

    Vertical graft height in the maxillary sinus.

    Procedure: Osseodensification crestal sinsus graft

  • Implants length and width

    Placed implants length and width

    Procedure: Osseodensification crestal sinsus graft

Interventions

  • ProcedureOsseodensification crestal sinsus graft

    Osseodensification Mediated Maxillary Sinus Crestal Grafting

    Also known as: Maxillary sinus grafting via crestal approach, Maxillary sinus membrance perforation incidence

06

What researchers measure

Primary outcomes

  1. Maxillary sinus membrane perforation rate during osseodensification crestal sinus grafting procedure.

    Measure the incidence of sinus membrane perforation during osseodensification

    Time frame: During augmentation surgery

Secondary outcomes

  1. Maxillary sinus augmentation level

    The height and width of augmentation level

    Time frame: During augmentation surgery

07

Study locations

1 site
  • Versah, LLC
    Jackson, Michigan 49203, United States
08

References and documents

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 25467952 ↗
  • Huwais 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 27741329 ↗
  • Huwais 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 30427961 ↗
  • Baron 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 35567659 ↗
  • Arafat, 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05954273
Lead sponsor
Versah
Responsible party
Sponsor
First posted
Jul 20, 2023
Start date
Apr 3, 2023
Primary completion
Jul 31, 2023 (estimated)
Completion
Aug 28, 2023 (estimated)
Last update
Jul 24, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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