Retrospective Case Series - OSSIX Volumax Collagen Xenograft Scaffolding

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06187805
• Other study ID #: Ver 01
• Status: Enrolling by invitation
• Start date: November 16, 2023
• Est. completion date: February 2, 2024

Study information

• Verified date: January 2024
• Source: Old Orchard Periodontics and Implant Dentistry LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: February 2, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dental Implants

Intervention

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

Locations

Country	Name	City	State
United States	Old Orchard Periodontics and Implant Dentistry	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Old Orchard Periodontics and Implant Dentistry LTD

Country where clinical trial is conducted

United States, 

Outcome

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