NCT05615051

Brief Summary

Two groups are aimed at being investigated in three centers (CICOM, Clinica Branemark and Clinica Joan Pi)

  • Test group: Group electrolytic approach (EA): Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes
  • Control group: Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze Patients´ group selection will be randomly allocated. For patients whom their personal clinical record # ends in a number from 0 to 4 will be included in the test group, while for patients whom their personal clinical record # ends from 5-9 will be included in the control group. The infra-osseous component will be regenerated using xenograft (Creos, NB) + autogenous bone in a ratio 1:1 harvested from the adjacent area. A resorbable membrane (Creos, NB) will be placed to compartmentalize the infra-osseous component following a poncho-like approach.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

2.9 years

First QC Date

November 7, 2022

Last Update Submit

June 5, 2025

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

  • Resolution of the disease

    No pocket depth \>6mm, no bleeding on probing, no suppuration, no progressive bone loss

    12 months

Secondary Outcomes (1)

  • Radiographic bone gain and clinical outcomes

    12 months

Study Arms (2)

Group electrolytic approach (EA)

EXPERIMENTAL

Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes

Device: Surface decontamination procedure aiming at reconstructive therapy

Group hydrogen peroxide (HP)

ACTIVE COMPARATOR

Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze

Device: Surface decontamination procedure aiming at reconstructive therapy

Interventions

Surface decontamination procedure aiming at reconstructive therapyDEVICE

Surface decontamination of infected implants followed by reconstructive therapy to manage peri-implantitis

Also known as: Hydrogen peroxide
Group electrolytic approach (EA)Group hydrogen peroxide (HP)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months.
  • All patients in age of 18 to 80
  • non-smokers
  • no presence of systemic disease or medication known to alter bone metabolism
  • partial or complete edentulous patients that have no active periodontal disease.

You may not qualify if:

  • pregnancy or lactation
  • history of or current smokers
  • uncontrolled medical conditions,
  • lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites,
  • advanced(A) peri-implantitis (\>50% of the implant length).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica CICOM

Badajoz, 06011, Spain

Location

Related Publications (1)

  • Monje A, Navarro-Mesa S, Soldini C, Zappala G, Pena P, Navarro JM Sr, Pons R. Surface Decontamination on the Reconstructive Therapy of Peri-Implantitis: A Multicenter Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Aug;27(4):e70075. doi: 10.1111/cid.70075.

    PMID: 40693504DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 14, 2022

Study Start

January 1, 2022

Primary Completion

December 10, 2024

Study Completion

July 10, 2025

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)