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

Study Overview
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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.

Official Title
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Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis: A Randomized Clinical Trial

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Device: Surface decontamination procedure aiming at reconstructive therapy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group electrolytic approach (EA)<br>Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes | Device: Surface decontamination procedure aiming at reconstructive therapy<br>* Surface decontamination of infected implants followed by reconstructive therapy to manage peri-implantitis<br>* Other names: Hydrogen peroxide;|
| Active Comparator: Group hydrogen peroxide (HP)<br>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<br>* Surface decontamination of infected implants followed by reconstructive therapy to manage peri-implantitis<br>* Other names: Hydrogen peroxide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of the disease | No pocket depth >6mm, no bleeding on probing, no suppuration, no progressive bone loss | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic bone gain | Bone gain when compared to baseline bone level | 12 months |