Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFreiburger Medizintechnik GmbH

About this trial

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

Qualifiers

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).

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • AmbiJet cold plasma system
  • Standard Mechanical Debridement (S3 Guideline)

Treatment groups

26 Participants
are divided into 2 treatment groups

Sponsors and collaborators