German Clinical Trials Register

Acronym/abbreviation of the study

Pilot_PeriPLas

URL of the study

No Entry

Brief summary in lay language

Patients with at least one dental implant with peri-implantitis can participate in this study. Peri-implantitis is a bacterial inflammation that has led to a significant reduction of the jaw bone at the implant. The disease causes so-called "gingival pockets" to form at the implant. Large amounts of bacteria are present on the implant, which are responsible for the occurrence and progression of bone loss. In the worst case, this can lead to the loss of the implant. For this reason, diseased implants must be thoroughly cleaned to fight the inflammation and stop or at least slow down the bone loss. To date, it has not been clarified which devices can rid the rough surface of the implants of bacteria so well that no further progression of bone loss occurs. Until now, treatment of the disease has involved surgically exposing the implant and removing the inflamed tissue. The exposed implant is then thoroughly cleared of bacterial plaque and disinfected using a sterile gauze pellet, a ball of gauze tissue. We have developed two new devices that we would like to examine comparatively with the previous treatment described in the previous section. One is a water jet device (name "Dental water jet"), which is used to clean the implant surface (similar to a high-pressure cleaner). The other is a plasma device (name "periINPlas"), which uses a cold plasma (with a temperature below 40°C), consisting of electrically positively and negatively charged gas particles, to chemically modify the implant surface so that, for example, water spreads on it instead of forming drops. These two products together bear the name "PeriPLas". We hope that the combination of these two devices will be more effective in cleaning the rough implant surface than the gauze pellet. We know from laboratory tests that the water jet can remove most bacteria from the rough implant surface and cold plasma can kill the remaining bacteria. By removing the bacteria and by chemically modifying the surface, it is hoped that the gum growth will be favored and in the long run the progression of bone resorption will be stopped or at least slowed down. Both the waterjet device and the plasma device are therapeutic medical devices under clinical investigation, meaning their efficacy and safety have been extensively tested in the laboratory, but they have not yet been approved by legal authorities for routine treatment of your condition outside of this clinical investigation. To date, there is no clinical experience with the use of these products for the treatment of peri-implantitis. However, there is already medical experience of successful treatment of poorly healing skin wounds with both devices.

Brief summary in scientific language

There is still no consensus among dentists as to which treatment method for periimplantitis leads to predictably good healing results in all cases. However, the loss of an implant as a dental prosthesis leads to pain, additional treatments, more costs and growing frustration for patients. Therefore, the need for novel treatment modalities is of utmost importance. This exploratory, multi-center, prospective, randomized clinical pilot study aims to provide effect estimates (with 95% confidence intervals) for a novel treatment (a water jet and a cold plasma device; test treatment) in comparison to treatment with a saline-soaked gauze pellet (control treatment) during an access flap surgery. By use of the Dental water jet, the biofilm-contaminated implant surface is cleaned. With cold plasma residual bacteria are reduced and the exposed surface is hydrophilized. The hydrophilic surface leads to an improved clot stabilization and this in turn to a better resolution of inflammation, shorter healing time and a more pronounced PPD reduction. The investigator examining the patient and the evaluators of data will be blinded. It is not possible to blind treating dentist and patient due to very different treatment modalities. The test treatment is characterized by waterflow, ozone smell, whereas the control treatment is soundless and odorless. Furthermore, this exploratory clinical investigation will allow us to estimate sample size requirements for a future pivotal clinical investigation to verify superiority of the test treatment (water jet and cold plasma device) for treatment of peri-implantitis.