Retrospective Case Series - OSSIX Volumax Collagen Xenograft Scaffolding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-16

Study Completion Date

2024-02-02

Brief Summary

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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.

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Detailed Description

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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

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Dental Implants

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Up to 15 patients

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

OSSIX Volumax

Intervention Type DEVICE

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

Interventions

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OSSIX Volumax

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes