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AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A monocentric Phase I pivotal pharmacology study for the determination of the local and systemic exposure of locally applied Minocycline in periodontal pockets via a newly developed pharmaceutical formulation for the treatment of patients with recurrent or persistent periodontitis

This research is looking into a new way to treat gum disease, also known as periodontitis. This common condition can cause your gums to become sore, bleed, and can even lead to tooth loss over time. The study is specifically testing a new gel containing a medicine called minocycline. This gel is designed to be applied directly into the gum pockets where the infection happens. Researchers want to understand how much of this medicine gets into your gums and how much might get into your bloodstream. This will help them see if the new treatment delivers a good amount of medicine where it's needed while also being safe for your whole body. It's for adults aged 18 and over who have persistent gum problems.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- Other
Sponsor
PerioTrap Pharmaceuticals GmbH
Enrolment target
24
Start
16 Oct 2023

What is this study about?

This study is about finding a better way to treat a common gum problem called periodontitis. Periodontitis happens when harmful bacteria build up in your mouth, causing your gums to become inflamed, bleed, and pull away from your teeth. If not treated, it can damage the bone supporting your teeth and eventually lead to tooth loss. Even after initial treatments, some people still have ongoing gum problems.

Researchers are testing a new type of treatment – a special gel containing a medicine called minocycline. Minocycline is an antibiotic, which means it helps fight off bacterial infections. The idea is to apply this gel directly into the deep pockets that form around your teeth due to gum disease. By putting the medicine exactly where it's needed, the hope is to clear up the infection more effectively.

The main goal of this particular study is to understand how the new minocycline gel behaves in your body. They want to see how much of the medicine stays in the gum pockets and how much might get absorbed into your overall system. This helps them work out the best dose and make sure the treatment is safe and reaches the right places to do its job.

Key takeaways

  • This study tests a new gel for persistent gum disease.
  • The gel contains an antibiotic called minocycline.
  • Researchers want to see how the medicine works in your gums and body.
  • It's for adults aged 18 and over who have ongoing gum problems.
  • Your participation helps to develop better treatments for gum disease.
  • All study-related care is free.

Who may be eligible?

This study is looking for adult volunteers aged 18 years and older. Both men and women can take part.

You would need to have ongoing or returning gum disease, known as periodontitis. This means your gum condition hasn't fully cleared up or keeps coming back.

There will be other health checks and requirements to make sure the study is right for you and safe. Only the study doctor can decide if you're a good fit.

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 18 years old or older?
  2. Do you have a diagnosis of ongoing or recurring periodontitis (gum disease)?
  3. Are you able to attend regular clinic visits?
  4. Are you generally in good health, apart from your gum condition?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be one of the first people to try this new minocycline gel. You would have several visits to the clinic where the study team will keep a close eye on your health. They'll apply the new gel to your gum pockets, and then they'll take samples (like small bits of gum tissue or blood) to check how much medicine is getting into your gums and your body. The study team will also do regular check-ups to see if the treatment is helping your gums and if you have any side effects. The exact number of visits, tests, and the total length of your involvement would be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if this new treatment helps your ongoing gum disease, though there's no guarantee it will work for everyone. You'd also be helping to advance medical knowledge, which could benefit others with similar conditions in the future. As with any medicine, there's always a chance of side effects or discomfort from the gel application or tests. The study team will explain all known and potential risks before you decide to take part. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Germany

Common questions

What is periodontitis?

Periodontitis is a serious gum infection that damages the soft tissue and bone supporting your teeth, and can lead to tooth loss if not treated.

What is minocycline?

Minocycline is a type of antibiotic medication used to fight bacterial infections in the body.

Why is this study important?

This study is important because it's looking for new and potentially better ways to treat ongoing gum disease, which affects many people.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study. All study-related treatments and tests will be provided free of charge.

Can I continue my usual dental care?

The study team will advise you on what dental care you can continue during the study. It's important to discuss this with them.

How to find out more

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

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