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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstanbul University

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Electrolytic Surface Decontamination

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Conventional Surgical Treatment AloneActive comparator 1 intervention
Group B: Conventional Surgical Treatment Plus Electrolytic Surface DecontaminationExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
24 Months

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: