Maxillary Sinus Membrane Perforation Incidence During Osseodensification

July 20, 2023 updated by: Versah

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Jackson, Michigan, United States, 49203
        • Versah, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sinus membrane perforation
Sinus membrane perforation incidences to measure the perforation rate.
Procedure: Osseodensification crestal sinsus graft
Osseodensification Mediated Maxillary Sinus Crestal Grafting
Other Names:
  • Maxillary sinus grafting via crestal approach
  • Maxillary sinus membrance perforation incidence
Alveolar bone height below the maxillary sinus floor
Pre-sinus augmentation alveolar bone ridge height.
Procedure: Osseodensification crestal sinsus graft
Osseodensification Mediated Maxillary Sinus Crestal Grafting
Other Names:
  • Maxillary sinus grafting via crestal approach
  • Maxillary sinus membrance perforation incidence
Maxillary sinus augementation level
Vertical graft height in the maxillary sinus.
Procedure: Osseodensification crestal sinsus graft
Osseodensification Mediated Maxillary Sinus Crestal Grafting
Other Names:
  • Maxillary sinus grafting via crestal approach
  • Maxillary sinus membrance perforation incidence
Implants length and width
Placed implants length and width
Procedure: Osseodensification crestal sinsus graft
Osseodensification Mediated Maxillary Sinus Crestal Grafting
Other Names:
  • Maxillary sinus grafting via crestal approach
  • Maxillary sinus membrance perforation incidence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During augmentation surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maxillary sinus augmentation level
Time Frame: During augmentation surgery
The height and width of augmentation level
During augmentation surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Estimated)

July 31, 2023

Study Completion (Estimated)

August 28, 2023

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ODSINUSPERF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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