Randomised, non-blinded study to investigate the Cleaning of infected implants with “GalvoSurge Dental Implant Cleaning System GS 1000” versus air abrasion.

Randomised, non-blinded study to investigate the Cleaning of infected implants with “GalvoSurge Dental Implant Cleaning System GS 1000” versus air abrasion. - DICSGS-1

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015689

Enrollment

Registered

2018-10-25

Start date

2018-08-23

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Periimplantitis K10.9

Interventions

Group 1: GalvoSurge Dental Implant Cleaning System GS 1000. For the electrolysis 200ml sodium formiate will be sprayed around an exposed dental implant for a duration of 2 minutes Group 2: Air-abras

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: The patient is 18 years or older. Adequate oral hygiene must have been established (BoP < 20% and Plaque Index < 20%). The patient is capable of understanding and giving informed consent. The patient has one or more implants. At least one implant has a Periimplantitis. The implant is an Titan-Implant. The implant has a diameter between 3.5 to 5 mm. The Titan-implant has one of the following surfaces: machiniert, sandblasting, sandblasting with acid etching. The Titan implant has Grade 2 / 4 / 5, is anodic oxidated to Titan Grade 4 or plasma sprayed to Grade 4. The depth of bone defect is < 8 mm The morphology of defect is augmentable (defect angle < 45°).

Exclusion criteria

Exclusion criteria: Medical and/or general contraindications for intraoral surgical procedure. Implants without Periimplantitis. Titan implants with a diameter 5 mm. Ceramic implants. Titan implants with ceramic coating. The depth of bone defect is > 8 mm. The morphology of defect is not augmentable (defect angle >45 °). Uncontrolled general Periodontitis. Smoking of =10 cigarettes/day. Allergy against antibiotics (1st choice amoxicillin-clavulanic acid, 2nd choice clindamycin). Allergy against local anaesthetics. Allegy against sodium formate in aqueous solution. Pregnancy and nursing women.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the safety endpoint. This endpoint is defined by the adverse events based on the individual adverse events reported by the investigator during treatment procedure and by the patient during treatment procedure and in the observation time after completion of treatment (14 days). The character and severity of adverse events are predefined.	—

Secondary

Measure	Time frame
The secondary endpoint is the efficacy endpoint as defined below. PCR 1 (polymerase chain reaction): after elevation of flap and removing of granulation tissue by smear. PCR 2: after therapy by smear. ? number of bacteria PCR1/PCR2 test versus ? number of bacteria PCR1/PCR2 control	—

Countries

Germany

Contacts

Public ContactRoger Eberle

GalvoSurge Dental AG

roger.eberle@galvosurge.com+41 71 747 11 44

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026