AmbiJet-assisted treatment for inflamed dental implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with inflammation around dental implants receive conventional mechanical cleaning, plus an additional treatment with the AmbiJet cold plasma system to see if it safely accelerates resolution of inflammation. The trial will assess safety, tolerability, and clinical signs of inflammation after treatment. Participants are adults aged 18 to 65 with one to five implants showing mucositis or peri-implantitis, and follow-up considerations follow standard guidelines. The study is conducted under the Freiburger Medizintechnik sponsorship at a single research site.

Why it matters

Who can join: the full rules

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).

Where it's running

• LLC "Institute of Implantological Research
  Romny, Ukraine Recruiting

Study contacts

• Study coordinator: Loic Ledernez, Phd
• Email: ledernez@frmed.de
• Phone: +49 176 96127565

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.