ClinicalTrials.gg
Not yet recruitingNCT07814391Galvo vs mechUpdated Sep 11, 2026

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

An Early Phase 1 interventional study of test device GalvoSurge and Mechanical decontamination with titanium brush in Peri-Implantitis and Peri-implant Mucositis, sponsored by George Eastman Dental Hospital, Italy. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by George Eastman Dental Hospital, Italy · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Peri-Implantitis and Peri-implant Mucositis

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Keywords

  • electrolytic cleaning
  • reconstructive treatment
  • demineralized bovine bone mineral (DBBM)
  • titanium brush
03

In context

Peri-Implantitis

322 studies on the registry are indexed under Peri-Implantitis; 88 are open to participants now.

This study's planned enrollment of 38 is close to the median of 40 across 195 interventional studies indexed under Peri-Implantitis.

Browse Peri-Implantitis studies →

Lead sponsor

George Eastman Dental Hospital, Italy is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 use, conditions affecting connective tissue)
  • smoking more than 10 cigarettes

Exclusion criteria

Exclusion Criteria:

  • mobile implants
  • non removable crowns (both cement or screw retained) that cannot be removed prior to surgery
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Test: Electrolytic decontamination

    Electrolytic decontamination with GalvoSurge (Straumann AG)

    Procedure: test device GalvoSurge

  • Experimental
    Control: Mechanical decontamination with rotating titanium brush

    Mechanical rotating brush used with titanium curettes to remove hard tissue deposits from the implant surface

Interventions

  • Proceduretest device GalvoSurge

    Electrolytic decontamination

    Also known as: electrolytic decontamination

  • ProcedureMechanical decontamination with titanium brush

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

    Also known as: tibrush

06

What researchers measure

Primary outcomes

  1. Change in Probing pocket depth

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

    Time frame: from baseline to 12, 24 months post-surgery

Secondary outcomes

  1. change in recession

    change between baseline and 24 months (mm)

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

  2. change in CAL

    change in CAL between baseline and 24 months (mm)

    Time frame: between baseline and 24 months

  3. Suppuration on probing (SoP)

    Dichotomic variable

    Time frame: baseline, 12, 24 months

  4. Bleeding on probing

    Dichotomic variable (yes/ no)

    Time frame: baseline, 12, 24 months

  5. Keratinized mucosa (KM)

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

    Time frame: 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)

    Time frame: 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

Time frame: duration of study

Access criteria: all de-identified information

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Apr 2027, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2026
First posted
Sep 11, 2026
StartEst.
Jan 2027
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07814391
Lead sponsor
George Eastman Dental Hospital, Italy
Responsible party
Lucrezia Paternò Holtzman (PhD candidate, George Eastman Dental Hospital, Italy) — Principal investigator
First posted
Sep 11, 2026
Start date
Jan 2027 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Sep 11, 2026

Study contacts

Lucrezia Paterno Holtzman, DDS, MS
Contact
lucreziaph@gmail.com
+393398035371
Luca Cordaro, DDS MD
Contact
lucacordaro@usa.net

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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