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RECRUITING

NCT07722715

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

Sponsor: Freiburger Medizintechnik GmbH

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02-14

Completion Date

2026-11-20

Last Updated

2026-07-23

Healthy Volunteers

Conditions

Peri Implant Mucositis Peri Implantitis

Interventions

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.

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.

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).

Locations (1)

LLC "Institute of Implantological Research

Romny, Ukraine