Reconstructive Treatment of Peri-implantitis With Electrolytic Decontamination Versus Titanium Brushes: a Randomized Controlled Trial
| Registry | NCT07814391, acronym Galvo vs mech |
|---|
| Status | Not yet recruiting |
|---|
| Phase | Early Phase 1 |
|---|
| Study type | Interventional; randomized, parallel, masking: single, treatment |
|---|
| Enrollment | 38 (Estimated) |
|---|
| Sponsor | George Eastman Dental Hospital, Italy (Other) |
|---|
| Conditions | Peri-Implantitis and Peri-implant Mucositis |
|---|
| Interventions | test device GalvoSurge, Mechanical decontamination with titanium brush (Procedure) |
|---|
| Dates | start 2027-01-01 (estimated), primary completion 2027-04-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-09-11, last updated 2026-09-11 |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Peri-Implantitis and Peri-implant Mucositis All trials of test device GalvoSurge All trials of Mechanical decontamination with titanium brush
-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.
Expand all sections · Collapse all
+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Test: Electrolytic decontamination | Experimental | Procedure: test device GalvoSurge | Electrolytic decontamination with GalvoSurge (Straumann AG) |
| Control: Mechanical decontamination with rotating titanium brush | Experimental | | Mechanical rotating brush used with titanium curettes to remove hard tissue deposits from the implant surface |
- test device GalvoSurge (Procedure), also known as electrolytic decontamination: Electrolytic decontamination
- Mechanical decontamination with titanium brush (Procedure), also known as 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
+Outcome measures
Primary outcomes
- Change in Probing pocket depth [from baseline to 12, 24 months post-surgery]: distance (mm) between marginal mucosa and bottom of probable pocket
Secondary outcomes
- change in recession [baseline to 12 and 24 months post-op]: change between baseline and 24 months (mm)
- change in CAL [between baseline and 24 months]: change in CAL between baseline and 24 months (mm)
- Suppuration on probing (SoP) [baseline, 12, 24 months]: Dichotomic variable
- Bleeding on probing [baseline, 12, 24 months]: Dichotomic variable (yes/ no)
- Keratinized mucosa (KM) [baseline, 12, 24 months]: continuous, measured in mm, from the margin of the mucosa to the mucogingival junction
- Treatment Success [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)
+Eligibility
Sex: All, ages: 18 Years to any
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
+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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 35785819