BridgeMD
Compares treatment options for Ridge Augmentation
Official title Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®
ClinicalTrials.gov ID: NCT05584566
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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%).
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
- Petah Tikva, Israel
- Birmingham, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel; Petah Tikva, Israel; Birmingham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.