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

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

Status: Active, not recruiting

Conditions: Peri-Implantitis

Treatments: Device: Surface decontamination procedure aiming at reconstructive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05615051

31102022

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group electrolytic approach (EA)

Experimental group

Description:

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

Treatment:

Device: Surface decontamination procedure aiming at reconstructive therapy

Group hydrogen peroxide (HP)

Active Comparator group

Description:

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

Treatment:

Device: Surface decontamination procedure aiming at reconstructive therapy