Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis (AmbiJet-FIH)

Background:

Developments in materials, improvements in techniques, and knowledge of the influence of patient characteristics have led to the increasing use of endosseous dental implants. Initially, a bony connection to the implant surface is established, but biofilm deposits on the implant and associated inflammatory reactions of varying severity can develop, namely peri-implant mucositis and peri-implantitis.

Peri-implant mucositis is the early stage of the disease: a reaction of the soft tissue (gums) around the implant. Peri-implantitis is the advanced stage of the disease and refers to inflammation that has a negative effect on integration into the bone.

Studies from university and private clinics with at least 100 implants reported between 2005 and 2014 showed prevalence data of 43% - 46.83% for peri-implant mucositis and 19.83% - 22% for peri-implantitis. Peri-implant mucositis and periimplantitis have bacterial pathogenesis, although the spectrum of microorganisms varies. Peri-implantitis is more serious because it attacks the bony implant support apparatus and can lead to implant loss in half of all cases. Treatment of peri-implant mucositis counteracts the development of peri-implantitis.

Therefore, according to the S3 guideline, three months of follow-up care is indicated.

The cause of inflammatory peri-implant inflammation is the development of a biofilm, which may be mineralized or non-mineralized. Biofilm is the three-dimensional organization of extracellular matrix and microorganisms that make up dental plaque or plaque in the periodontal pocket. Mineralized and non-mineralized biofilm is removed with a curette using non-surgical, mechanical debridement.

However, a recent survey of professionals shows that debridement may be less successful than assumed.

The S3 guideline acknowledges that peri-implant mucositis may not necessarily heal using conventional methods and that peri-implantitis should be treated using alternative methods such as monotherapy with Er:YAG laser or glycine-based air polishing. Adjuvant antimicrobial photodynamic therapy can be used in the non-surgical treatment of peri-implantitis (S3 guideline, AWMF registration number: 083-023). There is a lack of evidence for a protocol that could counteract the development of secondary peri-implantitis. The AmbiJet treatment principle is based on the local application of cold atmospheric pressure plasma, which generates electrical pulses and reactive oxygen species with antibacterial effects locally and has a positive effect on implant-integrative cell processes. In this RCT, this innovative dental medical device will be used in the treatment of peri-implant mucositis and peri-implantitis to determine the success and safety of its use. The study pursues the hypothesis that the use of plasma will lead to a greater proportion of regression of peri-implant mucositis and periimplantitis after six months.

Short description of the investigational device and its intended use:

The device is the AmbiJet system, which consists of a base unit with an inserted gas cartridge and two interchangeable applicators that are used to apply the electrically conductive plasma converted from the gas in a targeted manner for the appropriate indication in connection with dental implants.

The "periSlide" applicator has been developed for the treatment of peri-implant mucositis where access via the periodontal pocket is possible; the "inDrive" applicator is suitable for the treatment of peri-implantitis with direct access to the implant surface (possibly with the superstructure removed and/or surgical open-flap intervention). The applicators are sterile, single-use items that are attached to the handpiece of the base station.

Design of the clinical Trial:

One qualifying dental implant per patient is randomized; if additional dental implants or adjacent teeth are affected, these are also documented. Randomization is performed separately for the individual diagnoses (parallel groups) per patient:

Dental implants with a diagnosis of peri-implantitis/ peri-implant mucositis. Blinding is not possible because the intervention can only be performed using a separate medical device. Each dental implant receives a treatment indicated in accordance with the guideline for periimplantitis, given the diagnosis and inclusion in the study. In addition, the dental implants randomized to the intervention group receive the study treatment with the AmbiJet system.

The study is designed as a pivotal, hypothesis-driven clinical trial. One dental implant per patient is evaluated for local inflammatory changes.

Preliminary data on this project are included in the manufacturer's evaluation documents and demonstrate an effective and safe medical device.

According to the S3 guideline, the diagnosis of peri-implant mucositis includes clinical signs of inflammation, bleeding on probing, and possibly an increase in probing depths relative to the initial findings, and results in an indication for treatment per diagnosed site on the implant.

According to the S3 guideline, the diagnosis of peri-implantitis includes: clinical signs of inflammation, bleeding on probing, possible suppuration, increase in probing depths relative to the initial findings or, if initial findings are not available, > 6 mm, radiological evidence of bone loss relative to the initial findings or, if initial findings are not available, > 3 mm apical to the imaginary rough-smooth border, and provides the indication for treatment per diagnosed site on the implant.