Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05584566

Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®

Led by Datum Dental LTD · Updated on 2024-10-16

65

Participants Needed

3

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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®).

CONDITIONS

Official Title

Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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.

Not Eligible

You will not qualify if you...

  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
  11. Concurrent or previous radiotherapy of head area.
  12. Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
  13. Smoking (over 10 cigarettes a day).
  14. Pregnant or lactating women.
  15. Women of childbearing potential, who are not using a highly effective method of birth control.
  16. Participation in another investigational device, drug, or biologics study within the last 24 weeks prior to study entry.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Hadassah Medical Center

Jerusalem, Israel

Actively Recruiting

2

Rabin Medical Center

Petah Tikva, Israel, 4928451

Actively Recruiting

3

University of Birmingham

Birmingham, United Kingdom

Actively Recruiting

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Research Team

G

Gavriel Chaushu, prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason® | DecenTrialz