Infected tooth implants Infected tooth implants
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible for participation in this study, subjects must meet all of the following criteria: - Aged 18 years or older - Diagnosed with peri-implantitis, defined as: - Progressive bone loss of =2 mm - Pocket probing depth (PPD) =5 mm with concomitant bleeding and/or suppuration on probing - Moderate bone loss (25–50% of implant height) - Presence of a Class I, IIa, IIb, or V bone defect - Adequate space around the implant to accommodate the Spray Head of the GalvoSurge® (minimum width of 10 mm) - The implant surface to be cleaned must not extend more than 8 mm apically from the implant shoulder - Implant must be located in the posterior region - Patient presents with a maximum PPS (Periodiek Parodontaal Screenen) score of 2, bleeding on probing (BOP) <20%, and plaque score <20% prior to treatment - Patients must accept that, if the suprastructure of the implant is identified as the cause of peri-implantitis (e.g., poor fit, low ti-base, or difficult-to-clean crown due to complex emergence profile or angulation), a new crown will be required
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they meet any of the following criteria: · Patients younger than 18 years · Patients with systemic medical conditions or diseases that may significantly affect immune function: uncontrolled diabetes, immunodeficiency disorders or current chemotherapy. · Patients treated with radiotherapy during follow- up in the head and neck region · Pregnant or lactating individuals (hormonal changes during these periods can affect oral health and microbial colonization) · Smoking or alcohol abuse · Class III and IV bone defect · No electrically conductive implants · Allergy to sodium formate or lactic acid · Implants that don’t correspond to the implant geometry (Figure 2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease resolution is defined as the absence of bleeding on probing and/or suppuration upon gentle probing (0.2 N), a probing pocket depth of <5 mm, and no progressive radiographic bone loss. | — |
Secondary
| Measure | Time frame |
|---|---|
| Qualitative and semi- quantitative biofilm composition (via LC-MS), bone loss (radiographic), changes in PPD, bleeding on probing, suppuration, patient-reported outcomes, esthetic parameters. | — |
Countries
Netherlands
Contacts
Erasmus MC, Universitair Medisch Centrum Rotterdam