Actively Recruiting
Ridge Augmentation Treatment Using OSSIX BREEZE vs Jason AE Membrane in Simultaneous Implantations. A Prospective, Randomized Controlled Trial.
Led by Datum Dental LTD · Updated on 2024-10-16
65
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective randomized controlled trial to evaluate bone formation and soft tissue healing in patients with ridge deficiencies undergoing simultaneous dental implantation. The study compares two types of pericardium membranes: a sugar cross-linked membrane called OSSIX Breeze and a native pericardium membrane called Jason. The goal is to assess differences in bone gain and soft tissue healing at 4 and 8 months after treatment. Participants will receive one of the two barrier membranes during their guided bone regeneration treatment for ridge augmentation. Eligible adults needing 1 to 3 dental implants and having buccal bone defects will be randomly assigned to either the OSSIX Breeze membrane group or the Jason membrane group. The trial involves close follow-up to evaluate healing outcomes at specified time points. During the study, participants will be monitored for bone gain at 4 months as the primary outcome measure. Researchers will assess oral hygiene, inflammation control, and overall healing progress through follow-up examinations. Participants are expected to maintain good oral hygiene and attend all scheduled visits. The study is sponsored by Datum Dental LTD and aims to provide clear information on the comparative performance of these two membranes in ridge augmentation procedures.
CONDITIONS
Brief Title
Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females, age 18 and above.
- General good health (ASA 1 and ASA 2).
- Adults with buccal bone defect, who need implant placement and guided bone regeneration treatment.
- Patient needs 1 to 3 implants.
- Good oral hygiene (full mouth plaque index less than 25%).
- Adequate control of inflammation (full mouth bleeding on probing less than 25%).
- Patient is willing to sign informed consent and participate.
- Patient is able to understand and comply with study procedures including good oral hygiene and attending follow-ups.
You will not qualify if you...
- Physical status ASA III or ASA IV.
- General contraindications for dental or surgical treatments.
- Inflammatory or autoimmune diseases of the oral cavity.
- Known collagen hypersensitivity.
- Sensitivity to porcine-derived materials.
- Autoimmune and connective tissue diseases such as systemic lupus erythematosus or dermatomyositis.
- Acute infection or inflammation at the implantation site.
- Diseases contraindicating stomatology, maxillo-facial surgery, implantology, periodontology, endodontology, or oral surgery.
- Disease of oral mucosa.
- Uncontrolled periodontal disease.
- Current or previous radiotherapy of the head area.
- Current or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
- Smoking over 10 cigarettes a day.
- Pregnant or lactating women.
- Women of childbearing potential not using highly effective birth control.
- Participation in another investigational device, drug, or biologics study within 24 weeks prior to entry.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive the assigned barrier membrane device during implant placement and ridge augmentation treatment.
1 visit (in-person)
Duration - 4 months
Participants attend follow-up visits to monitor healing and treatment outcomes after device implementation.
Approximately 4 follow-up visits (in-person)
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
Research Team
G
Gavriel Chaushu, prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here