Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis
Recruiting now · Not applicable
Conditions studied: Peri Implant Mucositis, Peri Implantitis
In brief
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.
Key facts
- Study ID
- NCT07722715
- Run by
- Freiburger Medizintechnik GmbH
- People needed
- 26
- Starts
- 2026-02-14
- Expected to finish
- 2026-11-20
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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).
Where it is running
- LLC "Institute of Implantological Research — Romny, Ukraine (enrolling)
Full record on ClinicalTrials.gov
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