Peri-implantitisNCT07644975
Electrolytic Surface Decontamination in the Surgical Treatment of Peri-implantitis: A Randomized Clinical Trial
A study testing Electrolytic Surface Decontamination and Conventional Surgical Treatment in people with Peri-implantitis, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Electrolytic Surface Decontamination and Conventional Surgical Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Istanbul University Faculty of Dentistry
Istanbul
Volkan Arısan, Professor, +90 2124400000
varisan@istanbul.edu.tr
Istanbul University Faculty of Dentistry
Istanbul
Volkan Arısan, Professor, +90 2124400000, varisan@istanbul.edu.tr
About this study
Official title: 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?
Read more
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
- Being tested
- Electrolytic Surface Decontamination, Conventional Surgical Treatment
- Keywords
- Peri-implantitis, Electrolytic Surface Decontamination, Implant Surface Decontamination
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrolytic Surface DecontaminationProcedure or 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 TreatmentProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Electrolytic Surface Decontamination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Arisan, Istanbul University
- Investigators
- Volkan Arısan, Professor, Principal investigator, Istanbul University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644975
- Sponsor's protocol ID
- IUFD-PI-GALVO-RCT-2026-05
- Status last verified
- May 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 41788049Monje 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.
PubMed 42047219Arisan 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.
PubMed 40464209
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Electrolytic Surface Decontamination in the Surgical Treatment of Peri-Implantitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07644975
- Acronym / sponsor ID
- IUFD-PI-GALVO-RCT-2026-05
- Conditions
- Peri-implantitis
- Keywords
- Peri-implantitis, Electrolytic Surface Decontamination, Implant Surface Decontamination
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Surgical Treatment Alone | Active comparator | Procedure: Conventional Surgical TreatmentParticipants 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 DecontaminationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrolytic Surface DecontaminationElectrolytic 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. | Procedure or surgery | Conventional Surgical Treatment Plus Electrolytic Surface Decontamination |
| Conventional Surgical TreatmentConventional 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. | Procedure or surgery | Conventional Surgical Treatment Alone |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 41788049Puisys 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.
- Results publication: PubMed 42047219Monje 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.
- Results publication: PubMed 40464209Arisan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Volkan Arısan, Professor principal investigator
Istanbul University Faculty of Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrolytic Surface Decontamination and Conventional Surgical Treatment in people with Peri-implantitis, run by Istanbul University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Volkan Arısan, Professor (+90 2124400000, varisan@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Pocket Depth (PPD) (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07644975, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.