💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
General criteria:
* 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.
Dental criteria:
* Current X-ray of the implant region available (\<= 6 months prior to first treatment).
* One to five implants with bone loss from the start of the part of the implant intended for osseointegration (X-ray findings).
* Bleeding and/or suppuration after or without probing at the implant in question (peri-implant mucositis/peri-implantitis).
* Clinical signs of inflammation (swelling, redness, soft tissue) on the implant in question (peri-implant mucositis/peri-implantitis).
* Average oral hygiene (i.e., brushing teeth at least twice a day).
Exclusion Criteria:
General criteria:
* 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).
* Eating disorders such as bulimia or anorexia nervosa.
* Use of antibiotics within the last 2 months prior to the start of the study.
* Application of local antibiotics in the oral cavity within the last 2 months prior to the start of the study.
* Use of antimicrobial mouthwashes within the last month before the start of the study.
* Anti-inflammatory medication within the last month before the start of the study.
* Pregnancy or breastfeeding.
* Alcoholism or drug abuse.
* Wound healing disorders.
* Immunosuppression.
* Condition following insertion of an electrical, electrically active, or electronic implant.
Dental criteria:
* An implant with bone loss \>6 mm from the start of the part of the implant intended for osseointegration (X-ray findings) (peri-implantitis).
* Pathological changes in the oral mucosa or gingiva, such as oral lichen planus, chronic recurrent aphthae, melanotic macula, precancerous lesions (e.g., leukoplakia), melanomas.
* Use of medically unacceptable types of treatment, therapies, or substances (off-label use of treatments for peri-implant mucositis or peri-implantitis).
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