Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis

NCT ID: NCT05615051

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-07-10

Brief Summary

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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.

Detailed Description

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Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group electrolytic approach (EA)

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

Group Type EXPERIMENTAL

Surface decontamination procedure aiming at reconstructive therapy

Intervention Type DEVICE

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

Group hydrogen peroxide (HP)

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

Group Type ACTIVE_COMPARATOR

Surface decontamination procedure aiming at reconstructive therapy

Intervention Type DEVICE

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

Interventions

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Surface decontamination procedure aiming at reconstructive therapy

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

Intervention Type DEVICE

Other Intervention Names

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Hydrogen peroxide

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinica CICOM

Badajoz, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 40693504 (View on PubMed)

Other Identifiers

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31102022

Identifier Type: -

Identifier Source: org_study_id

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