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NCT Number: NCT07814391

Reconstructive Treatment of Peri-implantitis With Electrolytic Decontamination Versus Titanium Brushes

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.

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Key information

Conditions

Peri-Implantitis and Peri-implant Mucositis Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

test device GalvoSurge

Procedure

Electrolytic decontamination

Other names: electrolytic decontamination

Mechanical decontamination with titanium brush

Procedure

Reconstructive treatment of peri-implantitis after removal of hard and soft tissue deposits from the implant surface followed by mechanical decontamination with titanium brush

Other names: tibrush

Primary outcomes

  1. 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

Secondary outcomes

  1. change in recession

    Time frame: baseline to 12 and 24 months post-op

    change between baseline and 24 months (mm)

  2. change in CAL

    Time frame: between baseline and 24 months

    change in CAL between baseline and 24 months (mm)

  3. Suppuration on probing (SoP)

    Time frame: baseline, 12, 24 months

    Dichotomic variable

  4. Bleeding on probing

    Time frame: baseline, 12, 24 months

    Dichotomic variable (yes/ no)

  5. Keratinized mucosa (KM)

    Time frame: baseline, 12, 24 months

    continuous, measured in mm, from the margin of the mucosa to the mucogingival junction

  6. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Cordaro, DDS MD

CONTACT

[email protected]

Lucrezia Paterno Holtzman, DDS, MS

CONTACT

[email protected]

+393398035371

Sponsors and collaborators

Lead sponsor

George Eastman Dental Hospital, Italy

Other

Registry information

Official study title

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

Acronym: Galvo vs mech

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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