Reconstructive Treatment of Peri-implantitis With Electrolytic Decontamination Versus Titanium Brushes (Galvo vs mech)

September 4, 2026 updated by: Lucrezia Paternò Holtzman, George Eastman Dental Hospital, Italy

Reconstructive Treatment of Peri-implantitis With Electrolytic Decontamination Versus Titanium Brushes: a Randomized Controlled Trial

Implants diagnosed with peri-implantitis and amenable for bone reconstructive treatment will be enrolled in the study. The implants will randomly be treated with either an electrolytic or a mechanical cleaning of the implant surface (with titanium brushes). In all cases, a bone graft will be used to rebuild missing bone.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Implants diagnosed with peri-implantitis and amenable for bone reconstructive treatment will be enrolled in the study. All implants will receive reconstructive therapy by means of a collagenated bone graft, however the method of decontamination will be randomized between electrolytic cleaning or titanium rotating brushes. In both cases, titanium curettes will be used to remove hard deposits on the implant surface and degranulation will be completed with curettes.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Implants with peri-implantitis (defined according to 2017 World Workshop definitions)
  • contained defects with infra osseous component amenable to reconstructive treatment
  • fixed and removable superstructures
  • patients with no systemic conditions affecting healing (uncontrolled diabetes mellitus, chronic corticosteroid use, autoimmune conditions affecting connective tissue)
  • smoking more than 10 cigarettes

Exclusion Criteria:

  • mobile implants
  • non removable crowns (both cement or screw retained) that cannot be removed prior to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Test: Electrolytic decontamination
Electrolytic decontamination with GalvoSurge (Straumann AG)
Procedure: test device GalvoSurge
Electrolytic decontamination
Other Names:
  • electrolytic decontamination
Experimental: Control: Mechanical decontamination with rotating titanium brush
Mechanical rotating brush used with titanium curettes to remove hard tissue deposits from the implant surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing pocket depth
Time Frame: from baseline to 12, 24 months post-surgery
distance (mm) between marginal mucosa and bottom of probable pocket
from baseline to 12, 24 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in recession
Time Frame: baseline to 12 and 24 months post-op
change between baseline and 24 months (mm)
baseline to 12 and 24 months post-op
change in CAL
Time Frame: between baseline and 24 months
change in CAL between baseline and 24 months (mm)
between baseline and 24 months
Suppuration on probing (SoP)
Time Frame: baseline, 12, 24 months
Dichotomic variable
baseline, 12, 24 months
Bleeding on probing
Time Frame: baseline, 12, 24 months
Dichotomic variable (yes/ no)
baseline, 12, 24 months
Keratinized mucosa (KM)
Time Frame: baseline, 12, 24 months
continuous, measured in mm, from the margin of the mucosa to the mucogingival junction
baseline, 12, 24 months
Treatment Success
Time Frame: 24 months
Composite outcome comprising implant not lost, no more than 1 mm of buccal recession, no more than 5 mm of PPD, no SOP, no more than 1 bleeding spot on probing, no loss of crestal bone (mm)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Eastman Dental Hospital, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

September 4, 2026

First Submitted That Met QC Criteria

September 4, 2026

First Posted (Actual)

September 11, 2026

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

duration of study

IPD Sharing Access Criteria

all de-identified information

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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