Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis
Randomized, Controlled, Exploratory Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis (AmbiJet-FIH)
Freiburger Medizintechnik GmbH
26 participants
Feb 14, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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 Criteria19
- 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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Interventions
Adjuvant 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.
Mechanical, non-surgical debridement of mineralized and non-mineralized biofilm, including rinsing with saline solution and powder jet treatment.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07722715