Retrospective Case Series - OSSIX Volumax Collagen Xenograft Scaffolding

• Conditions: Dental Implants
• Interventions: Device: OSSIX Volumax

• Registration Number: NCT06187805
• Lead Sponsor: Old Orchard Periodontics and Implant Dentistry LTD

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.

Study Timeline

• Study Start: 2023-11-16
• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2023-12-17
• Status Verified: 2024-01
• Primary Completion: 2024-01-01
• Study First Posted: 2024-01-03
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Study Completion: 2024-02-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Up to 15 patients	OSSIX Volumax	Patients who have had a transcrestal elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Old Orchard Periodontics and Implant Dentistry; 🇺🇸 Skokie, Illinois, United States