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

Sponsor
Istanbul University
Study ID
NCT07644975
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 — 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.

Study Details

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

Key Dates

First listed
Jun 12, 2026
Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Aug 1, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Probing Pocket Depth (PPD) [ Time Frame: 24 Months ]

Central Contacts

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