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

Sponsor
Freiburger Medizintechnik GmbH
Study ID
NCT07722715
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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 Dates

First listed
Jul 23, 2026
Start date
Feb 14, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2026
Completion
Nov 20, 2026

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Macroscopic tissue reaction measured via Implant Mucosal Index [ Time Frame: Baseline, 1 week, and 4 weeks after initial treatment ]

Central Contacts

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