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.
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
- Conditions the study is for
- Peri-Implantitis and Peri-implant Mucositis
- 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
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.
Luca Cordaro, DDS MD contact
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 group | Role | What they receive |
|---|---|---|
| Test: Electrolytic decontamination | Experimental | Electrolytic decontamination with GalvoSurge (Straumann AG) Receives: Procedure: test device GalvoSurge |
| Control: Mechanical decontamination with rotating titanium brush | Experimental | Mechanical 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.
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)
change in recession
change between baseline and 24 months (mm)
Measured: baseline to 12 and 24 months post-op
change in CAL
change in CAL between baseline and 24 months (mm)
Measured: between baseline and 24 months
Suppuration on probing (SoP)
Dichotomic variable
Measured: baseline, 12, 24 months
Bleeding on probing
Dichotomic variable (yes/ no)
Measured: baseline, 12, 24 months
Keratinized mucosa (KM)
continuous, measured in mm, from the margin of the mucosa to the mucogingival junction
Measured: baseline, 12, 24 months
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.
- First posted11 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peri-Implantitis and Peri-implant MucositisStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Eastman Dental Hospital, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucrezia Paternò Holtzman, George Eastman Dental Hospital, Italy
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 35322316Bernardi 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 37129321Zhu 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 38345170Schlee 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 31703404Bosshardt 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 35244779Gianfreda 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