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Peri-Implantitis and Peri-implant MucositisEarly Phase 1Galvo vs mechNCT07814391

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

A Early Phase 1 study testing test device GalvoSurge and Mechanical decontamination with titanium brush in people with Peri-Implantitis and Peri-implant Mucositis, run by George Eastman Dental Hospital, Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
test device GalvoSurge and Mechanical decontamination with titanium brush
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
No sites listed yet
Study dates
Jan 2027to Apr 2027
Phase
Early Phase 1
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

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Lucrezia Paterno Holtzman, DDS, MS contact

+393398035371

lucreziaph@gmail.com

Luca Cordaro, DDS MD contact

lucacordaro@usa.net

About this study

Official title: 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.

Read the 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.

Being tested
test device GalvoSurge, Mechanical decontamination with titanium brush
Keywords
electrolytic cleaning, reconstructive treatment, demineralized bovine bone mineral (DBBM), titanium brush
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • test device GalvoSurgeProcedure or surgery

    Also called electrolytic decontamination

    Electrolytic decontamination

  • Mechanical decontamination with titanium brushProcedure or surgery

    Also called tibrush

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

Study groups in NCT07814391
Study groupRoleWhat they receive
Test: Electrolytic decontaminationExperimentalElectrolytic decontamination with GalvoSurge (Straumann AG)
Receives: Procedure: test device GalvoSurge
Control: Mechanical decontamination with rotating titanium brushExperimentalMechanical rotating brush used with titanium curettes to remove hard tissue deposits from the implant surface

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Probing pocket depth

    distance (mm) between marginal mucosa and bottom of probable pocket

    Measured: from baseline to 12, 24 months post-surgery

Secondary outcomes (6)

  1. change in recession

    change between baseline and 24 months (mm)

    Measured: baseline to 12 and 24 months post-op

  2. change in CAL

    change in CAL between baseline and 24 months (mm)

    Measured: between baseline and 24 months

  3. Suppuration on probing (SoP)

    Dichotomic variable

    Measured: baseline, 12, 24 months

  4. Bleeding on probing

    Dichotomic variable (yes/ no)

    Measured: baseline, 12, 24 months

  5. Keratinized mucosa (KM)

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

    Measured: baseline, 12, 24 months

  6. Treatment Success

    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)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07814391
Sponsor's protocol ID
0801
Acronym
Galvo vs mech
Status last verified
Aug 2026
First submitted
4 Sep 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Zipprich H, Weigl P, Di Gianfilippo R, Steigmann L, Henrich D, Wang HL, Schlee M, Ratka C. Comparison of decontamination efficacy of two electrolyte cleaning methods to diode laser, plasma, and air-abrasive devices. Clin Oral Investig. 2022 Jun;26(6):4549-4558. doi: 10.1007/s00784-022-04421-0. Epub 2022 Mar 24.

    PubMed 35322316

  • Bernardi S, Qorri E, Botticelli G, Scarano A, Marzo G, Gatto R, Greco Lucchina A, Mortellaro C, Lupi E, Rastelli C, Falisi G. Use of electrical field for biofilm implant removal. Eur Rev Med Pharmacol Sci. 2023 Apr;27(3 Suppl):114-121. doi: 10.26355/eurrev_202304_31328.

    PubMed 37129321

  • Zhu Y, Xu Y, Ling Z, Zhao C, Xu A, He F. The biofilm removal effect and osteogenic potential on the titanium surface by electrolytic cleaning: An in vitro comparison of electrolytic parameters and five techniques. Clin Oral Implants Res. 2024 Apr;35(4):454-466. doi: 10.1111/clr.14245. Epub 2024 Feb 12.

    PubMed 38345170

  • Schlee M, Rathe F, Brodbeck U, Ratka C, Weigl P, Zipprich H. Treatment of Peri-implantitis-Electrolytic Cleaning Versus Mechanical and Electrolytic Cleaning-A Randomized Controlled Clinical Trial-Six-Month Results. J Clin Med. 2019 Nov 7;8(11):1909. doi: 10.3390/jcm8111909.

    PubMed 31703404

  • Bosshardt DD, Brodbeck UR, Rathe F, Stumpf T, Imber JC, Weigl P, Schlee M. Evidence of re-osseointegration after electrolytic cleaning and regenerative therapy of peri-implantitis in humans: a case report with four implants. Clin Oral Investig. 2022 Apr;26(4):3735-3746. doi: 10.1007/s00784-021-04345-1. Epub 2022 Mar 4.

    PubMed 35244779

  • Gianfreda F, Punzo A, Pistilli V, Bollero P, Cervino G, D'Amico C, Cairo F, Cicciu M. Electrolytic Cleaning and Regenerative Therapy of Peri-implantitis in the Esthetic Area: A Case Report. Eur J Dent. 2022 Oct;16(4):950-956. doi: 10.1055/s-0042-1750773. Epub 2022 Jul 4.

    PubMed 35785819

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing test device GalvoSurge and Mechanical decontamination with titanium brush in people with Peri-Implantitis and Peri-implant Mucositis, run by George Eastman Dental Hospital, Italy.

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 5 inclusion and 2 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Lucrezia Paterno Holtzman, DDS, MS (+393398035371, lucreziaph@gmail.com), 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 (time frame: from baseline to 12, 24 months post-surgery). 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 NCT07814391, which also lists 6 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 11 Sep 2026.

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