- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07644975
Electrolytic Surface Decontamination in the Surgical Treatment of Peri-implantitis: A Randomized Clinical Trial
Effectiveness of Electrolytic Surface Decontamination in the Surgical Treatment of Peri-Implantitis: A Randomized Controlled Clinical Trial
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Volkan Arısan, Professor
- Phone Number: +90 2124400000
- Email: varisan@istanbul.edu.tr
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul University Faculty of Dentistry
-
Contact:
- Volkan Arısan, Professor
- Phone Number: +90 2124400000
- Email: varisan@istanbul.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Surgical Treatment Alone
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 of peri-implantitis consisting of flap elevation, mechanical implant surface decontamination using a titanium brush, and hydrogen peroxide application according to the study protocol.
|
|
Experimental: Conventional Surgical Treatment Plus 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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Probing Pocket Depth (PPD)
Time Frame: 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.
|
24 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Volkan Arısan, Professor, Istanbul University Faculty of Dentistry
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUFD-PI-GALVO-RCT-2026-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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