Retrospective Case Series - OSSIX Volumax Collagen Xenograft Scaffolding

Old Orchard Periodontics and Implant Dentistry LTD

Status: Invitation-only

Conditions: Dental Implants

Treatments: Device: OSSIX Volumax

Study type: Observational

Funder types: Other

Identifiers

NCT06187805

Ver 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

15 participants in 1 patient group

Up to 15 patients

Description:

Patients who have had a transcrestal elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding.

Treatment:

Device: OSSIX Volumax