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

NCT07722715 | Recruiting

• 1 other identifier: 214-54-26
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peri Implant Mucositis; Peri Implantitis

Keywords

Plasma Medicine; Cold Atmospheric Plasma; AmbiJet

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Standard Mechanical Debridement (S3)

ACTIVE COMPARATOR

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)

AmbiJet Cold Plasma + Standard Debridement

EXPERIMENTAL

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.

Device: AmbiJet cold plasma system; Procedure: Standard Mechanical Debridement (S3 Guideline)

Interventions

AmbiJet cold plasma system DEVICE

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.

AmbiJet Cold Plasma + Standard Debridement

Standard Mechanical Debridement (S3 Guideline) PROCEDURE

Mechanical, non-surgical debridement of mineralized and non-mineralized biofilm, including rinsing with saline solution and powder jet treatment.

AmbiJet Cold Plasma + Standard Debridement; Standard Mechanical Debridement (S3)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Freiburger Medizintechnik GmbH: lead

Study Sites (1)

LLC "Institute of Implantological Research

Romny, 42001, Ukraine

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Loic Ledernez, Phd

CONTACT

+49 176 96127565; ledernez@frmed.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding is not possible due to the physical nature of the medical device intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, prospective exploratory study. One qualifying dental implant per patient is randomized into either the intervention group or the active control group.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: February 14, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)