Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®
This research study is looking at two different types of dental membranes – OSSIX® Breeze and Jason® – which are used when people need to have their jawbone strengthened or rebuilt before getting dental implants. This process is called ridge augmentation. The main goal is to see which membrane works best in helping new bone form and how well the gum tissue around the implant heals over time. Researchers will check on patients after 4 and 8 months. Patients in the study will need 1 to 3 dental implants and have a specific type of bone loss in their jaw. By comparing these two materials, the study hopes to improve the success of dental implant procedures for suitable patients.
At a glance
What is this study about?
This study is about helping people who need dental implants but don't have enough healthy jawbone. Sometimes, after a tooth is removed or due to other reasons, the bone in the jaw shrinks. This can make it difficult for a dental implant to be placed securely. To fix this, dentists can perform a procedure called 'ridge augmentation,' which basically means rebuilding or adding to the jawbone.
In this study, researchers are comparing two different materials used in this bone rebuilding process. Both materials are like thin coverings or 'membranes' that help guide new bone growth. One is called OSSIX® Breeze, and the other is Jason®. They want to find out which membrane helps the bone grow back better and which leads to healthier gum healing around the implant.
By comparing these two options, the study aims to figure out which membrane provides the best results for patients getting dental implants. This could help dentists worldwide choose the most effective treatment for people who need their jawbone strengthened, ultimately leading to more successful and long-lasting dental implants.
Key takeaways
- This study compares two materials (OSSIX® Breeze and Jason®) for jawbone repair.
- It aims to find the best way to help new bone grow for dental implants.
- Participation involves receiving one of the membranes and attending follow-up checks at 4 and 8 months.
- You need to be an adult in good health with specific dental needs to qualify.
- The study could help improve dental implant success for many patients.
- Your involvement is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult (18 years or older) and generally in good health. You should have a specific type of bone loss in your jaw that requires dental implants, and you'll need between 1 and 3 implants. It's also important to have good oral hygiene, meaning your teeth and gums are relatively clean and healthy.
There are certain reasons why you might not be able to join. For example, if you have severe health problems, serious inflammatory or autoimmune conditions, or known sensitivities to certain materials (like collagen or pig-derived products), you won't be eligible. Also, active infections in your mouth, uncontrolled gum disease, or a history of radiation to your head would prevent you from taking part.
Additionally, if you smoke more than 10 cigarettes a day, are pregnant or breastfeeding, or are a woman of childbearing age not using effective birth control, you cannot participate. If you've recently been part of another medical device or drug study, that might also exclude you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you generally in good health?
- Do you need 1 to 3 dental implants and have a specific jawbone issue?
- Do you have good oral hygiene (clean teeth and healthy gums)?
- Are you not pregnant, breastfeeding, or a woman of childbearing age not using effective birth control?
- Do you not smoke more than 10 cigarettes a day or have certain serious health conditions?
What does participation involve?
If you decide to join this study, you will be randomly assigned to receive one of the two dental membranes (OSSIX® Breeze or Jason®) during your dental implant procedure. You'll need to follow a schedule of appointments at the clinic for check-ups. Researchers will assess how well the bone is forming and how your gum tissue is healing, specifically at 4 and 8 months after the procedure. Throughout the study, you'll be expected to maintain good oral hygiene as advised by the dental team and attend all scheduled follow-up visits. The total duration of your active participation, including follow-up, will be at least 8 months.
Potential risks and benefits
Locations (3)
- Hadassah Medical CenterVerified postcodeJerusalem, Israel· Recruiting
- Rabin Medical CenterVerified postcodePetah Tikva, Israel· Recruiting
- University of BirminghamVerified postcodeBirmingham, United Kingdom· Recruiting
Common questions
What is ridge augmentation?
It's a dental procedure that rebuilds or adds bone to your jaw when there isn't enough to support a dental implant.
What are OSSIX® Breeze and Jason®?
These are special membrane materials used during ridge augmentation to help new bone grow and heal properly.
How will I know which membrane I receive?
You will be randomly assigned to one of the two membranes, meaning it's decided by chance, much like a coin flip.
Will I have regular check-ups?
Yes, you will have follow-up appointments to check on bone growth and healing, specifically at 4 and 8 months after your procedure.
Can I leave the study if I change my mind?
Absolutely. Your participation is voluntary, and you can withdraw from the study at any time without affecting your normal healthcare.
How to find out more
Gavriel Chaushu, prof
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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