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

NCT07644975 | Not Yet Recruiting

• 1 other identifier: IUFD-PI-GALVO-RCT-2026-05
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Peri-implantitis

Keywords

Peri-implantitis; Electrolytic Surface Decontamination; Implant Surface Decontamination

Outcome Measures

Primary Outcomes (1)

• Change in Probing Pocket Depth (PPD)

  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.

  24 Months

Study Arms (2)

Conventional Surgical Treatment Alone

ACTIVE COMPARATOR

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.

Procedure: Conventional Surgical Treatment

Conventional Surgical Treatment Plus Electrolytic Surface Decontamination

EXPERIMENTAL

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.

Procedure: Electrolytic Surface Decontamination

Interventions

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 Plus Electrolytic Surface Decontamination

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.

Conventional Surgical Treatment Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (2)

Istanbul University Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

Istanbul University Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Volkan Arısan, Professor

  Istanbul University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Volkan Arısan, Professor

CONTACT

+90 2124400000; varisan@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-05

Locations

TU (2)