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

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06187805

Enrollment

Registered

2024-01-03

Start date

2023-11-16

Completion date

2024-02-02

Last updated

2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants

Brief 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.

Interventions

DEVICEOSSIX Volumax

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

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026