Maxillary Sinus Membrane Perforation Incidence During Osseodensification

Sinus Floor Augmentation Clinical Trial

Official title:

Incidence of Maxillary Sinus Membrane Perforation During Osseodensification Crestal Sinus Grafting

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05954273
• Other study ID #: ODSINUSPERF
• Status: Enrolling by invitation
• Start date: April 3, 2023
• Est. completion date: August 28, 2023

Study information

• Verified date: July 2023
• Source: Versah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: August 28, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sinus Floor Augmentation
• Sinus Infection
• Sinusitis

Intervention

Procedure:
• Osseodensification crestal sinsus graft
Osseodensification Mediated Maxillary Sinus Crestal Grafting

Locations

Country	Name	City	State
United States	Versah, LLC	Jackson	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Versah

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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

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.

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maxillary sinus membrane perforation rate during osseodensification crestal sinus grafting procedure.	Measure the incidence of sinus membrane perforation during osseodensification	During augmentation surgery
Secondary	Maxillary sinus augmentation level	The height and width of augmentation level	During augmentation surgery