Electrolytic Surface Decontamination in the Surgical Treatment of Peri-implantitis: A Randomized Clinical Trial

NCT07644975 — Not applicable, Not yet recruiting, 80 participants, Istanbul University

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Effectiveness of Electrolytic Surface Decontamination in the Surgical Treatment of Peri-Implantitis: A Randomized Controlled Clinical Trial

Registry	NCT07644975
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	80 (Estimated)
Sponsor	Istanbul University (Other)
Conditions	Peri-implantitis
Interventions	Electrolytic Surface Decontamination, Conventional Surgical Treatment (Procedure)
Dates	start 2026-08-01 (estimated), primary completion 2029-08-01 (estimated), completion 2029-08-01 (estimated), first posted 2026-06-12, last updated 2026-06-12
Locations	2 sites in Turkey (Türkiye)

-Summary

The goal of this clinical trial is to learn whether adjunctive electrolytic surface decontamination can improve the outcomes of surgical treatment of peri-implantitis. The main questions it aims to answer are:

* Does electrolytic surface decontamination reduce probing pocket depth more effectively than conventional surgical treatment alone?
* Does electrolytic surface decontamination improve bleeding on probing, suppuration, and radiographic bone levels?

Researchers will compare conventional surgical treatment plus electrolytic surface decontamination with conventional surgical treatment alone.

Participants will:

* Receive surgical treatment for peri-implantitis
* Be randomly assigned to one of the two treatment groups
* Attend follow-up visits for clinical and radiographic examinations
* Undergo assessment of probing pocket depth, bleeding on probing, suppuration, and bone level changes during follow-up

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+Arms and interventions

Arm	Type	Interventions	Description
Conventional Surgical Treatment Alone	Active comparator	Procedure: Conventional Surgical Treatment	Participants assigned to this arm will receive conventional surgical treatment for peri-implantitis. Treatment will include flap elevation, mechanical implant surface decontamination using a titanium brush, and hydrogen peroxide application according to the study protocol.
Conventional Surgical Treatment Plus Electrolytic Surface Decontamination	Experimental	Procedure: Electrolytic Surface Decontamination	Participants assigned to this arm will receive conventional surgical treatment for peri-implantitis, including flap elevation, mechanical implant surface decontamination using a titanium brush. In addition, electrolytic surface decontamination will be performed according to the study protocol.

Electrolytic Surface Decontamination (Procedure): Electrolytic implant surface decontamination performed using the GalvoSurge system as an adjunct to conventional surgical treatment. The procedure is intended to remove biofilm and contaminants from the implant surface through an electrolytic cleaning process.
Conventional Surgical Treatment (Procedure): Conventional surgical treatment of peri-implantitis consisting of flap elevation, mechanical implant surface decontamination using a titanium brush, and hydrogen peroxide application according to the study protocol.

+Outcome measures

Primary outcomes

Change in Probing Pocket Depth (PPD) [24 Months]: Change in peri-implant probing pocket depth (PPD) measured in millimeters at treated implant sites. The difference between baseline and 24-month follow-up measurements will be evaluated.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

Adults aged 18 years or older Diagnosis of peri-implantitis requiring surgical treatment Presence of at least one dental implant diagnosed with peri-implantitis Ability and willingness to attend follow-up visits Provision of written informed consent

Exclusion Criteria:

Pregnancy or lactation Uncontrolled systemic diseases that may affect healing Immunosuppressive therapy History of head and neck radiotherapy Current use of medications known to affect bone metabolism Inability to comply with the study protocol or follow-up schedule Previous surgical treatment of peri-implantitis at the study implant site

+Locations (2)

Facility	City	Country	Status
Istanbul University Faculty of Dentistry	Istanbul	Turkey (Türkiye)
Istanbul University Faculty of Dentistry	Istanbul	Turkey (Türkiye)

+Publications

Results publication: Puisys A, Akhondi S, Vindasiute-Narbute E, Zvirblis T, Gallucci GO, Pedrinaci I. Peri-Implant Reconstruction With Autogenous Bone and Electrolytic Therapy: A Randomized Controlled Clinical Trial. Clin Implant Dent Relat Res. 2026 Apr;28(2):e70123. doi: 10.1111/cid.70123. PMID 41788049
Results publication: Monje A, Reffassi MS, Valles C, Gourdache I, Kumar P, Nart J. Understanding peri-implantitis occurrence and recurrence following treatment: A patient-centered study. J Periodontol. 2026 Apr 28. doi: 10.1002/jper.70133. Online ahead of print. PMID 42047219
Results publication: Arisan V, Saglanmak A, Anil A, Arici SV, Sculean A. Photodynamic Therapy as an Adjunct to Resective and Regenerative Surgical Treatment of Peri-Implantitis: A Prospective Cohort of 72 Patients Followed for 18 Months. Oral Health Prev Dent. 2025 Jun 3;23:305-314. doi: 10.3290/j.ohpd.c_2078. PMID 40464209

+Investigators

Volkan Arısan, Professor, Principal investigator, Istanbul University Faculty of Dentistry