Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®

Last updated: October 14, 2024
Sponsor: Datum Dental LTD
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

OSSIX Breeze

Jason membrane

Clinical Study ID

NCT05584566
DD-OG-01
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 goingthrough 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 clinicalstudy.

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

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 arecontraindicated.

  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-dosecorticosteroid 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 ofbirth control.

  16. Participation in another investigational device, drug, or biologics study within thelast 24 weeks prior to study entry.

Study Design

Total Participants: 65
Treatment Group(s): 2
Primary Treatment: OSSIX Breeze
Phase:
Study Start date:
December 01, 2022
Estimated Completion Date:
July 01, 2026

Connect with a study center

  • Soroka Medical Center

    Be'er Sheva,
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem,
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, 4928451
    Israel

    Active - Recruiting

  • University of Birmingham

    Birmingham,
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.