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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Dental Implants
• Intervention / Treatment: Device: OSSIX Volumax

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.

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Old Orchard Periodontics and Implant Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Up to 15 participants who meet the I/E will have data retrospectively reviewed and will include follow up data.

Description

Inclusion Criteria:

1. Transcrestal sinus lift planned
2. Implant therapy planned
3. Crestal bone height < or equal to 6mm
4. Missing tooth or teeth for function
5. Nonsmoker -

Exclusion Criteria:

1. Patients with known collagen hypersensitivity
2. Patients with sensitivity to porcine-derived materials
3. Patients suffering from autoimmune diseases and connective tissue diseases, such as lupus erythematosus, dermatomyositis, etc.
4. Pregnant or planning to become pregnant (verbal confirmation)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Up to 15 patients; Patients who have had a transcrestal elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding.	Device: OSSIX Volumax; OSSIX Volumax is used in combination with autogenous bone collected during preparation of the implant osteotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in crestal bone height	Measured radiographically and by cone beam computed tomography at follow up	4 months to 57 months

Collaborators and Investigators

• Sponsor: Old Orchard Periodontics and Implant Dentistry LTD

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): February 2, 2024

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Ver 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No