All studies
Active not recruitingOBSERVATIONAL

Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures

This study is observing how well a dental product called RTR+Membrane works and how safe it is for people needing certain dental treatments. This membrane helps rebuild bone during procedures like preserving the tooth socket after an extraction, adding bone to the jaw, or when placing dental implants. Instead of a traditional clinical trial where treatments are strictly controlled, this is an 'observational study.' This means researchers will simply watch and record what happens to patients already receiving this treatment in their normal dental practice. They'll measure how well wounds heal in the months after surgery using check-ups, photos, and X-rays. The aim is to understand the performance and safety of this membrane in everyday dental care for adults aged 18 to 89.

At a glance

Status
Active not recruiting
Sponsor
Septodont
Enrolment target
90
Start
09 Feb 2024
Estimated completion
01 May 2026

What is this study about?

This study is all about understanding how a specific dental product, called RTR+Membrane, performs when used by dentists in their everyday practice. This membrane is designed to help your body rebuild bone in areas of your mouth that might need it after certain dental treatments. For example, if you have a tooth taken out, this membrane can help preserve the bone in that socket, making it easier if you wanted a dental implant later. It can also be used to add more bone where needed or to help with bone regrowth when an implant is put in straight after a tooth removal.

Researchers want to see how well these treatments work in real life, rather than in a strictly controlled lab setting. They are especially interested in how well the treated area heals in the months following your surgery. They will be looking at things like how the wound looks, how the bone density changes, and whether there are any problems. This information is important because it helps dental professionals and patients understand the effectiveness and safety of this membrane in typical dental procedures.

By carefully observing patients who are already receiving these treatments, the study gathers valuable information about the long-term results of using RTR+Membrane. This helps improve future dental care and ensures that the best and safest treatments are available for people needing bone regeneration in their mouth.

Key takeaways

  • This study observes outcomes for a dental membrane used to help bone regeneration.
  • It's for adults needing specific dental bone and implant treatments.
  • Participation involves your regular dental care, with extra check-ups, photos, and X-rays.
  • The goal is to understand how well the membrane works and if it's safe in everyday practice.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult patient (between 18 and 89 years old) who is already planning to have one of three specific dental treatments using the RTR+Membrane. These treatments include preserving the empty socket after a tooth is removed, adding bone to your jaw (called alveolar ridge augmentation), or having a dental implant placed immediately after a tooth extraction where bone regeneration is also needed.

You should also be part of a social security system and must give your written permission to take part by signing an informed consent form. The study is open to both men and women.

There are some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, have an active infection in the area being treated, or if you need several complex dental treatments in different areas at the same time. Heavy smokers (more than 10 cigarettes a day) are also not suitable, nor are people receiving certain medications like long-term steroids or some cancer treatments. If you have poorly controlled conditions like diabetes, certain autoimmune diseases, or chronic infections at the surgical site, you would also not be able to participate. Finally, people who might have difficulty understanding or completing questionnaires on their own are also excluded.

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.

  1. Are you an adult patient (18-89 years old)?
  2. Are you having a tooth removed and the socket preserved, or jaw bone added, or an immediate implant with bone regeneration?
  3. Are you not pregnant or breastfeeding?
  4. Are you not a heavy smoker (more than 10 cigarettes a day)?
  5. Do you not have active infections in the treatment area or poorly controlled chronic illnesses like severe diabetes or autoimmune diseases?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be followed throughout your regular dental treatment and follow-up appointments. There will be several visits where information is collected. At your surgery appointment (V1), the dental team will record some general information about you, your medical history, and details about your dental treatment, including the use of the membrane. They'll also perform a check-up, take photographs, and likely X-rays or a more detailed 3D scan (CBCT).

You'll have early follow-up visits (V2 and V2bis), which might include removing stitches if needed. During these visits, there will be a clinical check-up, more photographs, and you might be asked to complete a questionnaire. Finally, you'll have a late follow-up visit (V3) where you'll have another check-up, photographs, X-rays or CBCT scans, and another questionnaire. You will continue to follow your dentist's usual instructions regarding your medication and aftercare.

Potential risks and benefits

This study is observational, meaning you'll receive the dental treatment you already need. The main benefit is that your treatment outcomes will be carefully monitored, and your participation contributes to valuable knowledge about the performance and safety of the RTR+Membrane in real-world settings. As with any dental procedure, there are potential risks associated with the surgery itself, such as infection or discomfort, which your dentist will discuss with you. There are no additional risks specific to the study beyond the standard care you would receive. You are free to withdraw from the study at any time without affecting your medical care.

Locations (9)

  • Hospital University of Nantes
    Verified postcode
    Nantes, France
  • Private dental practice office of Dr. Alain Hoornaert
    Verified postcode
    Nantes, France
  • Private dental practice office of Dr. Samer Saloum-Rouxel
    Verified postcode
    Nantes, France
  • Private dental practice office of Dr. Xavier Struillou
    Verified postcode
    Nantes, France
  • Private dental practice office of Dr. Edouard Lanoiselée
    Verified postcode
    Nozay, France
  • Private dental practice office of Dr. Aurélien Fruchet
    Verified postcode
    Olonne-sur-Mer, France
  • Private dental practice office of Dr. Hélène Le Hécho
    City only
    Orée d'Anjou, France
  • Private dental practice office of Dr. Nicolas Strube
    Verified postcode
    Orvault, France
  • Private dental practice office of Dr. Romain Besnier
    Verified postcode
    Orvault, France

Common questions

What is the RTR+Membrane?

It's a special material used in dentistry to help your body rebuild and grow new bone after tooth extractions or during dental implant procedures.

Is this a new treatment?

The study aims to observe how this membrane works in real-life dental practices, so it's a product that dentists are already using.

Will I get extra treatment or medication?

No, you will receive the standard dental treatment you already require. The study just involves carefully observing and recording your progress.

How long will I be followed for?

You will be followed for several months after your dental surgery, with a few scheduled visits to check your healing and progress.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care or relationship with your dentist.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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