Maxillary Sinus Membrane Perforation Incidence During Osseodensification

NCT ID: NCT05954273

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-03

Study Completion Date

2023-08-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Sinus Floor Augmentation Sinus Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sinus membrane perforation

Sinus membrane perforation incidences to measure the perforation rate.

Osseodensification crestal sinsus graft

Intervention Type PROCEDURE

Osseodensification Mediated Maxillary Sinus Crestal Grafting

Alveolar bone height below the maxillary sinus floor

Pre-sinus augmentation alveolar bone ridge height.

Osseodensification crestal sinsus graft

Intervention Type PROCEDURE

Osseodensification Mediated Maxillary Sinus Crestal Grafting

Maxillary sinus augementation level

Vertical graft height in the maxillary sinus.

Osseodensification crestal sinsus graft

Intervention Type PROCEDURE

Osseodensification Mediated Maxillary Sinus Crestal Grafting

Implants length and width

Placed implants length and width

Osseodensification crestal sinsus graft

Intervention Type PROCEDURE

Osseodensification Mediated Maxillary Sinus Crestal Grafting

Interventions

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Osseodensification crestal sinsus graft

Osseodensification Mediated Maxillary Sinus Crestal Grafting

Intervention Type PROCEDURE

Other Intervention Names

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Maxillary sinus grafting via crestal approach Maxillary sinus membrance perforation incidence

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Versah

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Versah, LLC

Jackson, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25467952 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27741329 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30427961 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 35567659 (View on PubMed)

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

Reference Type BACKGROUND

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)

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 8636166 (View on PubMed)

Other Identifiers

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ODSINUSPERF

Identifier Type: -

Identifier Source: org_study_id

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