NCT05954273

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2023

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 12, 2023

Last Update Submit

July 20, 2023

Conditions

Sinus Floor AugmentationSinus Infection

Outcome Measures

Primary Outcomes (1)

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

    Measure the incidence of sinus membrane perforation during osseodensification

    During augmentation surgery

Secondary Outcomes (1)

  • Maxillary sinus augmentation level

    During augmentation surgery

Study Arms (4)

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

Osseodensification crestal sinsus graftPROCEDURE

Osseodensification Mediated Maxillary Sinus Crestal Grafting

Also known as: Maxillary sinus grafting via crestal approach, Maxillary sinus membrance perforation incidence
Alveolar bone height below the maxillary sinus floorImplants length and widthMaxillary sinus augementation levelSinus membrane perforation

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • History of radiotherapy,
  • Bisphosphonate medication.
  • Active periodontal disease.
  • Uncontrolled diabetes.
  • Heavy smoking (\> 20 cigarettes/day).
  • Local acute apical abscess.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Versah, LLC

Jackson, Michigan, 49203, United States

Location

Related Publications (9)

  • 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.

    PMID: 25467952BACKGROUND

  • 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.

    PMID: 27741329BACKGROUND

  • 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.

    PMID: 30427961BACKGROUND

  • 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.

    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.

    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.

    PMID: 35567659BACKGROUND

  • 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

    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)

    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.

    PMID: 8636166BACKGROUND

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 20, 2023

Study Start

April 3, 2023

Primary Completion

July 31, 2023

Study Completion

August 28, 2023

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations

US(1)