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

Randomized, Controlled, Exploratory Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis (AmbiJet-FIH)

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.

Study Overview

• Status: Recruiting
• Conditions: Peri Implantitis; Peri Implant Mucositis
• Intervention / Treatment: Procedure: Standard Mechanical Debridement (S3 Guideline); Device: AmbiJet cold plasma system

Detailed Description

Background:

Developments in materials, improvements in techniques, and knowledge of the influence of patient characteristics have led to the increasing use of endosseous dental implants. Initially, a bony connection to the implant surface is established, but biofilm deposits on the implant and associated inflammatory reactions of varying severity can develop, namely peri-implant mucositis and peri-implantitis.

Peri-implant mucositis is the early stage of the disease: a reaction of the soft tissue (gums) around the implant. Peri-implantitis is the advanced stage of the disease and refers to inflammation that has a negative effect on integration into the bone.

Studies from university and private clinics with at least 100 implants reported between 2005 and 2014 showed prevalence data of 43% - 46.83% for peri-implant mucositis and 19.83% - 22% for peri-implantitis. Peri-implant mucositis and periimplantitis have bacterial pathogenesis, although the spectrum of microorganisms varies. Peri-implantitis is more serious because it attacks the bony implant support apparatus and can lead to implant loss in half of all cases. Treatment of peri-implant mucositis counteracts the development of peri-implantitis.

Therefore, according to the S3 guideline, three months of follow-up care is indicated.

The cause of inflammatory peri-implant inflammation is the development of a biofilm, which may be mineralized or non-mineralized. Biofilm is the three-dimensional organization of extracellular matrix and microorganisms that make up dental plaque or plaque in the periodontal pocket. Mineralized and non-mineralized biofilm is removed with a curette using non-surgical, mechanical debridement.

However, a recent survey of professionals shows that debridement may be less successful than assumed.

The S3 guideline acknowledges that peri-implant mucositis may not necessarily heal using conventional methods and that peri-implantitis should be treated using alternative methods such as monotherapy with Er:YAG laser or glycine-based air polishing. Adjuvant antimicrobial photodynamic therapy can be used in the non-surgical treatment of peri-implantitis (S3 guideline, AWMF registration number: 083-023). There is a lack of evidence for a protocol that could counteract the development of secondary peri-implantitis. The AmbiJet treatment principle is based on the local application of cold atmospheric pressure plasma, which generates electrical pulses and reactive oxygen species with antibacterial effects locally and has a positive effect on implant-integrative cell processes. In this RCT, this innovative dental medical device will be used in the treatment of peri-implant mucositis and peri-implantitis to determine the success and safety of its use. The study pursues the hypothesis that the use of plasma will lead to a greater proportion of regression of peri-implant mucositis and periimplantitis after six months.

Short description of the investigational device and its intended use:

The device is the AmbiJet system, which consists of a base unit with an inserted gas cartridge and two interchangeable applicators that are used to apply the electrically conductive plasma converted from the gas in a targeted manner for the appropriate indication in connection with dental implants.

The "periSlide" applicator has been developed for the treatment of peri-implant mucositis where access via the periodontal pocket is possible; the "inDrive" applicator is suitable for the treatment of peri-implantitis with direct access to the implant surface (possibly with the superstructure removed and/or surgical open-flap intervention). The applicators are sterile, single-use items that are attached to the handpiece of the base station.

Design of the clinical Trial:

One qualifying dental implant per patient is randomized; if additional dental implants or adjacent teeth are affected, these are also documented. Randomization is performed separately for the individual diagnoses (parallel groups) per patient:

Dental implants with a diagnosis of peri-implantitis/ peri-implant mucositis. Blinding is not possible because the intervention can only be performed using a separate medical device. Each dental implant receives a treatment indicated in accordance with the guideline for periimplantitis, given the diagnosis and inclusion in the study. In addition, the dental implants randomized to the intervention group receive the study treatment with the AmbiJet system.

The study is designed as a pivotal, hypothesis-driven clinical trial. One dental implant per patient is evaluated for local inflammatory changes.

Preliminary data on this project are included in the manufacturer's evaluation documents and demonstrate an effective and safe medical device.

According to the S3 guideline, the diagnosis of peri-implant mucositis includes clinical signs of inflammation, bleeding on probing, and possibly an increase in probing depths relative to the initial findings, and results in an indication for treatment per diagnosed site on the implant.

According to the S3 guideline, the diagnosis of peri-implantitis includes: clinical signs of inflammation, bleeding on probing, possible suppuration, increase in probing depths relative to the initial findings or, if initial findings are not available, > 6 mm, radiological evidence of bone loss relative to the initial findings or, if initial findings are not available, > 3 mm apical to the imaginary rough-smooth border, and provides the indication for treatment per diagnosed site on the implant.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Loic Ledernez, Phd; Phone Number: +49 176 96127565; Email: ledernez@frmed.de

Study Locations

• Ukraine
  • Romny, Ukraine, 42001
    • Recruiting
    • LLC "Institute of Implantological Research
    • Contact: Dmytro Kaplun, Phd; Phone Number: +38(066) 700-59-25; Email: da8in4eg@gmail.com
    • Principal Investigator: Kaplun Kaplun, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Mechanical Debridement (S3); Guideline-compliant standard therapy only, consisting of mechanical, non-surgical debridement of mineralized and non-mineralized biofilm, including rinsing with saline solution and powder jet treatment.	Procedure: Standard Mechanical Debridement (S3 Guideline); Mechanical, non-surgical debridement of mineralized and non-mineralized biofilm, including rinsing with saline solution and powder jet treatment.
Experimental: AmbiJet Cold Plasma + Standard Debridement; 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.	Procedure: Standard Mechanical Debridement (S3 Guideline); Mechanical, non-surgical debridement of mineralized and non-mineralized biofilm, including rinsing with saline solution and powder jet treatment.; Device: AmbiJet cold plasma system; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macroscopic tissue reaction measured via Implant Mucosal Index	Evaluation of local acute tissue reactions and toxicity in the peri-implant mucosa using the Implant Mucosal Index (IMI). The IMI scale ranges from a minimum score of 0 (healthy tissue, no signs of inflammation) to a maximum score of 3 (severe inflammation, pronounced swelling, spontaneous bleeding, or pus discharge). Higher scores indicate a worse outcome (more severe tissue inflammation).	Baseline, 1 week, and 4 weeks after initial treatment
Acute pain and post-interventional morbidity measured via Visual Analog Scale	Measurement of the intensity of the patient's pain response during and after treatment using a Visual Analog Scale (VAS). The VAS scale ranges from a minimum score of 0 (no pain) to a maximum score of 10 (worst imaginable pain). Higher scores indicate a worse outcome (greater pain intensity).	Immediately after treatment, 1 week, and 4 weeks after initial treatment

Collaborators and Investigators

• Sponsor: Freiburger Medizintechnik GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 20, 2026

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Plasma Medicine; Cold Atmospheric Plasma; AmbiJet
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Peri-Implantitis
• Other Study ID Numbers: 214-54-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No