Clinical trial NCT05954273: Maxillary Sinus Membrane Perforation Incidence During Osseodensification
Official title: Incidence of Maxillary Sinus Membrane Perforation During Osseodensification Crestal Sinus Grafting
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Sinus Floor Augmentation
Sinus Infection
Lead sponsor: Versah
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maxillary sinus membrane perforation rate during osseodensification crestal sinus grafting procedure.
timeFrame: During augmentation surgery
Secondary outcomes:
measure: Maxillary sinus augmentation level
timeFrame: During augmentation surgery
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Versah, LLC
state: Michigan
Study officials:
References:
citation: 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.
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.
citation: 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.
citation: 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.
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.
citation: 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.
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
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)
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.