Inflammation of the tissue surrounding a dental implant (peri-implantitis or peri-implant mucositis) can lead to implant loss in advanced stages. The AmbiJet system utilizes cold atmospheric plasma (CAP), a physical procedure with a strong antibacterial effect. This clinical trial investigates whether the additional application of cold plasma directly on the patient following conventional mechanical cleaning of the implants is safe, well-tolerated, and resolves inflammation more quickly compared to standard treatment.
Men or women aged >= 18 and <= 65 years.
For women of childbearing age: a form of contraception recognized by conventional medicine during the study.
Written consent has been obtained from each patient for the study.
Current X-ray of the implant region available (<= 6 months prior to first treatment).
Known allergies to materials used in the study (gold, copper, polyimide).
Diabetes (type I or type II), vasculitis, osteoporosis, osteomalacia.
Smokers (>1 cigarette/week).
Use of medications to modulate bone metabolism (e.g., bisphosphonates).
Parallel
AmbiJet cold plasma system
DeviceAdjuvant application of cold atmospheric pressure plasma using the AmbiJet system directly onto the affected implant surfaces, performed immediately following standard mechanical debridement according to the S3 guideline.
Standard Mechanical Debridement (S3 Guideline)
Procedure/SurgeryMechanical, non-surgical debridement of mineralized and non-mineralized biofilm, including rinsing with saline solution and powder jet treatment.
Macroscopic tissue reaction measured via Implant Mucosal Index
Evaluation of local acute tissue reactions and toxicity in the peri-implant mucosa using the Implant Mucosal Index (IMI). The IMI scale ranges from a minimum score of 0 (healthy tissue, no signs of inflammation) to a maximum score of 3 (severe inflammation, pronounced swelling, spontaneous bleeding, or pus discharge). Higher scores indicate a worse outcome (more severe tissue inflammation).
Acute pain and post-interventional morbidity measured via Visual Analog Scale
Measurement of the intensity of the patient's pain response during and after treatment using a Visual Analog Scale (VAS). The VAS scale ranges from a minimum score of 0 (no pain) to a maximum score of 10 (worst imaginable pain). Higher scores indicate a worse outcome (greater pain intensity).
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