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NCT Number: NCT05584566

Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®

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®).

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Center, Jerusalem, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females, age 18 and above.
  • General good health (ASA 1 and ASA 2).
  • Adults with buccal bone defect, who are in need of implant placement, and going through a guided bone regeneration treatment.
  • Patient needs 1-3 implants.
  • Good oral hygiene (full mouth plaque index <25%).
  • Adequate control of inflammation (full mouth bleeding on probing <25%).
  • 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

  • Physical status ASA III or ASA IV.
  • General contraindications for dental and/or surgical treatments.
  • Inflammatory and autoimmune disease of the oral cavity.
  • Patients with known collagen hypersensitivity.
  • Patients with sensitivity to porcine-derived materials.
  • Patients suffering from autoimmune diseases and connective tissue diseases, such as: systemic lupus erythematosus, dermatomyositis, etc.
  • Acute infection in the oral cavity or acute inflammation at the implantation site.
  • General diseases, where measures of stomatology, maxillo-facial surgery, implantology, periodontology, endodontology or other measures of oral surgery are contraindicated.
  • Disease of oral mucosa.
  • Uncontrolled periodontal disease
  • Concurrent or previous radiotherapy of head area.
  • Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
  • Smoking (over 10 cigarettes a day).
  • Pregnant or lactating women.
  • Women of childbearing potential, who are not using a highly effective method of birth control.
  • Participation in another investigational device, drug, or biologics study within the last 24 weeks prior to study entry.

Treatment and study plan

OSSIX Breeze

Device

barrier membrane

Jason membrane

Device

barrier membrane

Primary outcomes

  1. increase in bone gain

    Time frame: 4 months

    increase in bone gain (vertical and horizontal) in mm, 4 months after the implant placement in the augmented site. the measurment will be done according to radiographic images

Study contacts

Contact information is provided by the study sponsor or research team.

Gavriel Chaushu, prof

CONTACT

[email protected]

+97239377207

Sponsors and collaborators

Lead sponsor

Datum Dental LTD

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2022
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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