Clinically controlled randomized trial with Heidelberg University Hospital.

The influence of different decontamination protocols on soft tissue and osseous regeneration of infected implant surfaces.

Background

The replacement of missing teeth (due to loss or non-attachment) with endosseous oral implants is one of the established therapies in modern dentistry. The number of dental implants placed is steadily increasing and now stands at 1.3 million per year in Germany. This is associated with a continuous increase in early and late complications. The latter includes peri-implantitis, which presents as a primarily bacterial inflammation around osseointegrated, functionally loaded implants with progressive loss of peri-implant bone structures. Therapy of peri-implant inflammation that cannot be treated conservatively includes surgical peri-implantitis therapy, in which the contaminated implant surface is exposed and cleaned in a surgical procedure under local anesthesia by forming a mucoperiosteal flap. A variety of surgical protocols are available for this purpose, in which augmentation measures are performed in addition to smoothing the rough implant surfaces (implantoplasty). The aim is to eliminate peri-implant inflammation, stabilize the soft tissue and prevent further peri-implant bone resorption. However, none of the different protocols has led to clinically significantly better results, and peri-implantitis has remained a difficult disease to treat to this day. A new therapeutic approach is the removal of the biofilm by an electrolytic cleaning procedure in which electrolysis is performed between an anode and the cathodically switched implant. The resulting hydrogen dissolves and removes the biofilm matrix and should ensure complete decontamination of the exposed implant surfaces.

Targets

The aim of this randomized clinical trial is to investigate the influence of an electrolytic cleaning procedure in surgical peri-implantitis therapy. The working hypothesis is that the use of an electrolytic cleaning procedure will result in significantly improved soft tissue and bone regeneration compared to conventional surgical therapy.

Methodology

The study will be conducted as a two-arm controlled randomized trial over a one-year period. Include 41 patients without serious preexisting conditions with ≥1 implant who meet clinical and radiographic criteria for peri-implantitis and for whom surgical peri-implantitis therapy is indicated.
The following baseline parameters are collected: probing depth, position of the gingival margin by intraoral scan, plaque index, BOP, determination of the HbA1c level on the day of surgery, suppuration of pus, PROMs and taking baseline radiographs (two-dimensional). All measurements are performed at 4 sites per implant (mesiobuccal, mesiolingual, distobuccal, distolingual). After the initial measurements, randomized assignment to the control group (group 1) is performed: Mucoperiosteal flap + removal of granulation tissue + irradiation of the implant with glycine powder + bone augmentation with xenogenic bone graft substitute or to the test group (group 2): Mucoperiosteal flap + removal of granulation tissue + treatment of the implant surface with an electrolytic cleaning system (GS1000 GalvoSurge® Nobel Biocare, Kloten, Switzerland) + bone augmentation with xenogenic bone substitute material. Both groups received antibiotic treatment for 5 days postoperatively. Postoperative measurements are performed at 6 and 12 months by a blinded investigator. The primary endpoint is the change in probing depth in millimeters.

Potential risks

The study-related measures represent surgical therapy of existing peri-implantitis and are therefore associated with general complications: Pain, swelling, bleeding, post-operative bleeding, wound healing disorder, wound infection. Because the study-related procedures are a medically indicated procedure, there are no additional risks or burdens associated with participation in the study. There are no restrictions on the use of the “GalvoSurge Dental Implant Cleaning System GS 1000” for patients with pacemakers or patients with implanted defibrillators. The geometry of the spray head and the choice of electrolysis voltage ensure that the resulting electric and magnetic field is at least a factor of 4 below the limit values.

Download PDF: Information leaflet for patients

Download PDF: Informed consent to participate in the study

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