RecruitingNAINTERVENTIONAL

The Adjunctive Effect of Soft Tissue Augmentation Procedures of Moderate-severe Peri-implantitis

Dental implants are popular, but sometimes a gum disease called peri-implantitis can develop around them. This study is exploring different ways to treat this condition. When you have peri-implantitis, surgery is often needed to clean around the implant and reshape the bone. This research aims to compare what happens when people get additional gum tissue treatment as part of their surgery, against those who don't. We're looking at two types of extra gum tissue treatment: using some of your own tissue, or a special collagen material. The main goal is to find out if these extra steps help to clear up the infection and improve the overall healing and health around the implant, compared to just having the standard surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Nadja Naenni

Enrolment target

120

Start

31 Oct 2022

Estimated completion

01 Dec 2029

Peri-Implantitis

What is this study about?

Dental implants are a common way to replace missing teeth, but sometimes problems can arise. One such problem is peri-implantitis, which is basically a gum disease that affects the tissues and bone around a dental implant. It's a bit like gum disease (periodontitis) that affects natural teeth, but it happens around implants.

When peri-implantitis occurs, it often means there's an infection, and the gum and bone around the implant can become inflamed and damaged. This study is important because more and more people are getting dental implants, so finding the best ways to treat peri-implantitis is really vital. Currently, while there are treatments, we don't have one method that's clearly better than all others.

Often, surgery is needed to properly clean the implant and the affected bone. Sometimes, this surgery can lead to the gum tissue shrinking away, which isn't ideal for the health or look of the implant. This research is trying to see if adding an extra step to the surgery—where we essentially thicken or improve the gum tissue using either a small piece of your own tissue or a special collagen material—can help get rid of the infection more effectively and reduce problems like gum recession. We're comparing these extra steps to just having the standard surgery, to see which approach works best for patients.

Key takeaways

This study explores better treatments for peri-implantitis around dental implants.
It compares standard surgery with additional gum tissue treatments.
Gum tissue treatments involve either your own tissue or a special collagen material.
The main aim is to see if adding gum tissue helps clear the infection more effectively.
Participation involves surgery and follow-up checks on your implant health.

Who may be eligible?

To be considered for this study, you need to be an adult over 18 years old. You must have at least one dental implant that has been in place for at least a year and has been diagnosed with peri-implantitis. This diagnosis means you have signs of infection like bleeding or pus when the implant area is gently checked, and there's also some bone loss around the implant.

It's important that you generally have good oral health, meaning your other teeth and gums are healthy, and you have good daily tooth brushing habits. You also need to be able to understand the study information and be willing to give your permission to take part.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, have allergies to certain materials or medications (like penicillin or common pain relievers), or if you smoke heavily. If you have active gum disease elsewhere in your mouth, or have difficulty understanding or following study instructions, you wouldn't be able to participate either.

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 an adult aged 18 or older?
Do you have at least one dental implant with peri-implantitis?
Do you have good overall gum health and brushing habits?
Are you able to understand and follow study instructions?
Are you not pregnant, breastfeeding, or a heavy smoker?

Answer every question to see your result.

What does participation involve?

This study is comparing three different ways to treat peri-implantitis after surgery. You would be randomly placed into one of these groups. One group will have a standard surgery to clean the implant and bone. Another group will have this standard surgery plus a small piece of your own gum tissue taken from another part of your mouth and placed around the implant. The third group will have the standard surgery plus a special collagen material placed around the implant.

Throughout the study, you would attend regular appointments for checks on your implant and overall gum health. This will involve gentle measurements and examinations. The total duration of your participation in the study, including follow-up appointments, is not specified in detail but typically involves several visits over a period of months to a year or more to assess long-term healing.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that you might receive a treatment that proves to be more effective at resolving your peri-implantitis compared to standard care, which could improve the long-term health of your dental implant. There is also the benefit of contributing to medical knowledge that may help future patients. Potential risks could include those normally associated with dental surgery, such as discomfort, swelling, bruising, or a small risk of infection. If you receive an additional gum tissue graft, there would be a small extra surgical site where the tissue is taken from. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt
Verified postcode
Frankfurt, Germany· Not yet recruiting
National Dental Centre Singapore
Verified postcode
Singapore, Singapore· Not yet recruiting
Clinic of Reconstructive Dentistry, Center of Dental Medicine University of Zurich
Verified postcode
Zurich, Switzerland· Recruiting

Common questions

What is peri-implantitis?

It's a gum disease that affects the tissues and bone around a dental implant, similar to gum disease around natural teeth.

What does 'soft tissue augmentation' mean?

It means adding or improving the gum tissue around the implant, either with a small piece of your own tissue or a special material.

Will I get to choose my treatment group?

No, you will be randomly assigned to one of the treatment groups, like flipping a coin, to ensure the study is fair.

Are dental implants very common?

Yes, they are a popular way to replace missing teeth, which is why finding the best treatments for problems like peri-implantitis is important.

What if I feel uncomfortable during the study?

You are free to leave the study at any time, and this will not affect your normal dental care.

How to find out more

Jolanta Boruta

jolanta.boruta@zzm.uzh.ch +41446343260 Official trial record

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