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Galvosurge vs NaCl

Treatment of peri-implantitis: electrolytic cleaning vs NaCl decontamination of the implant surface. A randomized controlled trial - Galvosurge versus NaCl

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON61223
Enrollment
40
Registered
2025-07-21
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infected tooth implants Infected tooth implants

Interventions

All participants will receive pre-operative conventional periodontal therapy which includes scaling- and rootplaning and professional oral hygiene instructions. Surgical treatment involves open flap d

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

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

MeasureTime 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

MeasureTime 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

Public ContactLN Latif

Erasmus MC, Universitair Medisch Centrum Rotterdam

l.nurzad@erasmusmc.nl+31624085083

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026