NCT06187805

Retrospective Case Series - OSSIX Volumax Collagen Xenograft Scaffolding

Retrospective Case Series Evaluating the Outcome of Transcrestal Sinus Elevation Using Autogenous Bone Supporting an OSSIX Volumax Collagen Xenograft Scaffolding

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Old Orchard Periodontics and Implant Dentistry LTD · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study is designed as a retrospective, single center study. Up to 15 participants who had a transcrestal sinus elevation and implant placement using autogenous bone supporting an OSSIX Volumax collagen xenograft scaffolding will be enrolled. The study will include data collection from medical records and data collected at a follow up visit between January 2019 and March 2023.

Detailed description

The purpose of this study is to evaluate the outcome of transcrestal sinus elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding. Data to be collected includes demographics, past medical history including autoimmune diseases and connective tissue diseases, smoking history and known allergies. Implant data will be collected and change in crestal bone height will be measured radiographically and cone beam computed tomography at follow up. The protocol will include both single-staged and two-staged procedures. Adverse events will be collected and reported.

Conditions

• Dental Implants

Interventions

Type	Name	Description
DEVICE	OSSIX Volumax	OSSIX Volumax is used in combination with autogenous bone collected during preparation of the implant osteotomy.

Timeline

• Start date: 2023-11-16
• Primary completion: 2024-01-01
• Completion: 2024-02-02
• First posted: 2024-01-03
• Last updated: 2024-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study