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NCT07722715
Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis
Conditions: Peri Implant Mucositis, Peri Implantitis
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 26
Sponsor: Freiburger Medizintechnik GmbH
Location: LLC "Institute of Implantological Research Romny
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 Criteria
Inclusion Criteria:
General criteria:
* Men or women aged \>= 18 and \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).
Source: ClinicalTrials.gov (NCT07722715). StuddyBuddy aggregates publicly available trial information.