Maxillary Sinus Membrane Perforation Incidence During Osseodensification

• Conditions: Sinus Floor Augmentation; Sinus Infection
• Interventions: Procedure: Osseodensification crestal sinsus graft

• Registration Number: NCT05954273
• Lead Sponsor: Versah

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.

Study Timeline

• Study Start: 2023-04-03
• Status Verified: 2023-07
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-20
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24
• Primary Completion: 2023-07-31
• Study Completion: 2023-08-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sinus membrane perforation	Osseodensification crestal sinsus graft	Sinus membrane perforation incidences to measure the perforation rate.
Maxillary sinus augementation level	Osseodensification crestal sinsus graft	Vertical graft height in the maxillary sinus.
Implants length and width	Osseodensification crestal sinsus graft	Placed implants length and width
Alveolar bone height below the maxillary sinus floor	Osseodensification crestal sinsus graft	Pre-sinus augmentation alveolar bone ridge height.

Primary Outcome Measures

Name	Time	Method
Maxillary sinus membrane perforation rate during osseodensification crestal sinus grafting procedure.	During augmentation surgery	Measure the incidence of sinus membrane perforation during osseodensification

Secondary Outcome Measures

Name	Time	Method
Maxillary sinus augmentation level	During augmentation surgery	The height and width of augmentation level

Trial Locations

Locations (1)

Versah, LLC; 🇺🇸 Jackson, Michigan, United States