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Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason® | Clinical Trials | Clareo Health

RECRUITINGNA

Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®

Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason® Membrane in Simultaneous Implantations. A Prospective, Randomized Controlled Trial.

NCT05584566•Datum Dental LTD

View on ClinicalTrials.gov

Summary

This is a prospective randomized controlled parallel trial. The aim of this study is to evaluate bone formation and soft tissue healing after 4 and 8 months in patients with ridge deficiencies in simultaneous implantation approach. The trial will compare a (sugar cross linked) - SCL pericardium membrane OSSIX® Breeze vs native pericardium membrane (Jason®).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females, age 18 and above.
•2. General good health (ASA 1 and ASA 2).
•3. Adults with buccal bone defect, who are in need of implant placement, and going through a guided bone regeneration treatment.
•4. Patient needs 1-3 implants.
•5. Good oral hygiene (full mouth plaque index \<25%).
•6. Adequate control of inflammation (full mouth bleeding on probing \<25%).
•7. Patient is willing to sign an informed consent and participate in the clinical study.
•10 8. Patient is able to understand and comply with the study related procedures, such as exercising good oral hygiene and attending all follow-up examinations.

Exclusion Criteria

•1. Physical status ASA III or ASA IV.
•2. General contraindications for dental and/or surgical treatments.
•3. Inflammatory and autoimmune disease of the oral cavity.
•4. Patients with known collagen hypersensitivity.
•5. Patients with sensitivity to porcine-derived materials.
•6. Patients suffering from autoimmune diseases and connective tissue diseases, such as: systemic lupus erythematosus, dermatomyositis, etc.
•7. Acute infection in the oral cavity or acute inflammation at the implantation site.
•8. General diseases, where measures of stomatology, maxillo-facial surgery, implantology, periodontology, endodontology or other measures of oral surgery are contraindicated.
•9. Disease of oral mucosa.
•10. Uncontrolled periodontal disease
+6 more criteria

Locations (3)

Hadassah Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

University of Birmingham

Birmingham, United Kingdom

Key Dates

Start Date

December 1, 2022

Primary Completion Date

June 1, 2026

Completion Date

July 1, 2026

Last Updated

October 16, 2024

Enrollment

ESTIMATED participants

Conditions

Ridge Augmentation

Interventions

OSSIX Breeze

DEVICE

Jason membrane

DEVICE

Contacts

Gavriel Chaushu, prof

CONTACT

+97239377207 GavrielCe@clalit.org.il

Comparison of Non Perforated Titanium Foil Over Collagen Membrane in Ridge Augmentation.

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Ridge Augmentation

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COMPLETEDNA

Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone

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Symphysis Onlay Bone GraftPlatelet Rich Fibrin+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®

Inclusion Criteria

Exclusion Criteria

Comparison of Non Perforated Titanium Foil Over Collagen Membrane in Ridge Augmentation.

Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone

A Novel Approach for Horizontal Augmentation: A Split Box

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One-stage Versus Two-stage Inverted U-shaped Ridge Splitting